Clinical Trial Manager remote jobs - 254 jobs

Global Trial Associate- Global Clinical Operations Leadership Development Program (GCO-LDP)- Full-Time Class of 2026
8427-Janssen Cilag Manufacturing Legal Entity
Remote job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All Job Posting Locations: Irvine, California, United States of America, Los Angeles, California, United States of America, San Diego, California, United States of America, Spring House, Pennsylvania, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine Remote work options may be considered on a case-by-case basis and if approved by the Company. We are searching for the best talent for the Global Trial Associate- Global Clinical Operations Leadership Development Program (GCO-LDP)- Full-Time Class of 2026. Purpose: The GCO Leadership Development Program consists of 12 months of dynamic rotations in Spring House, PA and Southern California locations (e.g Los Angeles, Irvine, San Diego). The Program provides in-depth training across the Clinical Trial Assistant, Site Manager, and potentially Local Trial Manager based on business need, supported by strong line management, formal mentorship, sponsorship, networking, focused leadership development and dynamic real world work experience. Global Trial Associates (GTAs) will rapidly gain knowledge, develop technical and leadership skills and important insights into how the business operates. These positions will be in the Immunology and Cross (e.g. Neuroscience, Retinol, and others) Therapeutic Areas. These positions will not be in the Oncology Therapeutic area. The objective is for the GTA to develop an understanding of pharmaceutical development, GCO standard operation procedures, policies and regulatory requirements, logistical and administrative tasks related to trial management (start-up, execution and closing phases) and patient safety in clinical trials. The GTA will gain knowledge of and support activities of the Site Manager (SM) and Program Manager, and/or Manager Clinical Operations (MCO). GTA's will support Local Trial Manager (LTM) positions under the direct supervision of LTM and SM mentors if there is a business need. Upon successful completion of the program, GTAs will be placed in a Site Manager role or potentially a Local Trial Manager role depending on business need and skillset. The GCO US Site Management organization is regionally aligned to the Northeast, Southeast, Central and West. This reduces the travel burden for Site Managers as they are assigned to study institutions based in their region. Local Trial Managers work remotely and are not regionally aligned as they don't have travel associated with their position. LTMs are project managers responsible for study deliverables in the US. Following completion of the program, GTAs moving into the SM role will work remotely in an assigned region in the U.S., where there is a business need. You will be responsible for: Provide administrative and logistical support to Clinical Trial Assistant (CTAs), Site Manager and/or Local Trial Manager in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence, materials, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies, and local regulatory requirements. Support the local study team in performing site feasibility and/or country feasibility. Collaborates with the Global Project Team, e.g. Trial Delivery Manager (TDM)/Trial Delivery Lead (TDL), local management/Country Head and other study team members, as required. Maintain information in relevant systems, including electronic filing (electronic Trial Master File: eTMF). Ensure current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable. Support Trial Delivery Manager, Site Manager and/or Local Trial manager in collecting/preparing documents required for study start-up/ submission to Ethics Committee/IRB and/or Health Authorities. Support Trial Delivery Manager, Site Manager and/or Local Trial Manager in collecting, processing, and archiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones. May assist team in conducting local investigator meeting or with planning for the investigators participating in an international meeting. Maintain and update contact information in relevant systems to ensure appropriate safety updates distribution. Comply with all training requirements, company policies & procedures and all applicable laws and regulations. Always act aligned with J&J Credo. Ensure inspection readiness at all times. May contribute to process improvement. Support Site Manager, within a reasonable timeframe, be able to take on responsibility in executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/ study close-out according to Standard Operating Procedures, Work Instructions (WIs) and policies. Qualifications / Requirements: Must be graduating between December 2025 and July 2026 with a bachelor's or master's degree (e.g., BA, BS, MS) in Health Sciences or a related scientific field (we will not be accepting PhD/Pharm D or Pre-Med applicants) Minimum GPA of 3.5 is required 1+ year of professional work experience is preferred (including internship, co-op or research experience) Ability to relocate to: Spring House, PA and work full-time (hybrid 3 days on-site/2 days remote) for the duration of the 1-year program California locations and work full-time for the duration of the 1-year program (hybrid and/or remote schedule will be determined on an individual basis) Geographic flexibility to relocate within the U.S. following completion of the program, if there is a business need Ability to travel as needed in the Site Manager rotation Permanently authorized to work in the United States, must not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship. Skills: Strong verbal and written communication and presentation skills Analytical and a real problem solver Willingness to learn in a dynamic environment and stay abreast of new technologies Strong interpersonal, leadership, and negotiating skills Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Ability to perform activities in a timely and accurate manner. Expert proficiency with Word, Power Point, Excel. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits, please go to: ********************************************* Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. #LI-Hybrid #LI-Remote #LI-Onsite Required Skills: Analytical Thinking, Microsoft Excel, Negotiation, PowerPoint Presentations, Problem Solving, Time Management Preferred Skills: Analytical Reasoning, Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trials The anticipated base pay range for this position is : $95,600/year Additional Description for Pay Transparency: This position is eligible for a sign-on bonus. Eligibility for severance.
$95.6k yearly Auto-Apply 16d ago

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Senior Clinical Trial Manager
Eyepoint Pharmaceuticals 4.5
Remote job
Be Seen and Heard at EyePoint At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for: preventing blindness through vision-saving medications delivering best-in-class proprietary pharmaceutical technologies transforming ocular drug delivery We See You. Your wellbeing Your professional worth Your future at EyePoint EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. This position is reporting to the Associate Director, Clinical Operations and is remote. Responsibilities Primary responsibilities include, but are not limited to, the following: Individual Responsibilities Key Clinical Operations role: ensures that delegated components of clinical trials are executed to expected and specified quality standards Expands basic knowledge of clinical trials operations and scientific principles and objectives of EyePoint's clinical trials under some direction and guidance of senior staff but largely self-directed; works independently but knows when to involve / collaborate with others Builds best practices in clinical operations methodologies, systems and processes, with particular emphasis on quality, time standards and expectations Manages study processes or efforts under the supervision of the Associate Director of Clinical Operations Authors/ reviews/ contributes to clinical study documents Reviews and approves study related plans generated by Clinical CROs and vendors Provides input as the subject matter expert for the study during regulatory inspections Executes the clinical study in accordance with the project clinical development strategy and timelines Contributes to the review of international study documents (e.g study protocol, ICF, etc.) and responsible for their local adaptation when necessary. Accountable for the timely clinical review and/or approval of Case Report Forms, User Acceptance Testing (UAT), and provides clinical input into corresponding completion guidelines Responsible for oversight of identification and selection of investigator sites Responsible for planning and conducting investigator's meetings in cooperation with the respective departments Ensure the delivery of clinical trial supplies in collaboration with the clinical supply team Collaborates with the cross functional team on selection and management of clinical vendors Manages escalation of study related issues and communicates as appropriate with management and other R&D functions Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight Trains and manages CRO and other clinical vendor activities to ensure the quality meets EyePoint and regulatory requirements Monitors the status of clinical data collection of assigned clinical studies Ensures preparation for regulatory agency inspections by developing and executing readiness plans, managing documentation, and facilitating cross-functional collaboration to maintain compliance with GMPGDP standards May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance Monitors progress of clinical activity and produces regular and ad hoc reports and presentations as required Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site / CRO / clinical vendor contact Responsible for the availability and tracking all relevant study information/ study metrics Oversees the resolution of data quality issues Reviews correspondence and monitoring reports relating to the study Evaluates CRO and vendor performance for future work Provides periodic status reports regarding study timelines, accruals, etc. to EyePoint Management as requested Reviews budgets and contracts with CROs, vendors, and investigative sites, as applicable Requests and critically evaluates proposals and change orders from CROs and vendors Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities Qualifications Primary skills and knowledge required include, but are not limited to the following: Preferred Qualifications Understanding of ICH-GCP guidelines, clinical trial monitoring, and/or regulatory compliance preferred Knowledgeable of current FDA and local IRBs regulatory requirements and guidelines governing clinical research. Ophthalmology experience strongly preferred Up to 20% domestic and/or international travel may be required Previous experience directing inspection readiness strongly preferred Bachelor's degree or nursing degree is required. Scientific/health care field preferred, but not required Global clinical trial experience and the ability to lead/manage more than one clinical trial Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands Ability to work independently and take initiative Ability to work/communicate successfully within a cross-functional team Strong knowledge of applicable computer and project management software packages Familiarity with financial budgeting and forecasting or reporting Respectfully challenges current practices, decisions, or ideas to promote quality and efficiency Excellent written and oral communication skills Strong interpersonal skill set to interact with investigators, vendors, and individuals at all levels of the organization Level of Education Required: Bachelor's degree at least preferred in Scientific/health care related field. Number of Years of Experience in the Function and in the Industry: 5+ years' experience working in clinical operations within a pharmaceutical company or CRO or similar organization Experience of at least 3 years as a Clinical Trial Manager/Project Manager or similar position within a pharmaceutical company or CRO Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below. #LI-Remote Min USD $146,260.00/Yr. Max USD $184,713.00/Yr.
$146.3k-184.7k yearly Auto-Apply 58d ago
Senior Clinical Trial Manager- APAC
Dianthus Therapeutics
Remote job
About Us We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology - enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation - enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit ****************** and follow us on LinkedIn. About the Role The Senior Clinical Trial Manager will be responsible for the oversight, operational direction and efficient operational planning and implementation of Dianthus clinical trials on either regional level. You will report to the APAC Clinical Operations lead and work with cross-functional team management to accelerate development of clinical assets. As the Sr Manager, you will act as Clinical Project Manager (CPM) responsible for implementation, execution and overall resource management of clinical studies being conducted by Dianthus, in particular in leading the delivery of our ongoing global Phase II/III studies and APAC regional support. You will be accountable to ensure all activities occur in compliance with the appropriate regulations and guidelines including ICH/GCP and be responsible to oversee and manage internal and external resources to ensure efficient patient recruitment/management, trial site selection/management, trial plan optimization and overall execution with a focus on quality. Fluency in English and Mandarin and/or experience working across multiple countries in the APAC region to best support all clinical trials and provide strategic input to all global studies is ideal. This is a unique opportunity where you have a chance to positively impact lives as part of the team driven by continuous innovation with very high scientific integrity. We are building a team who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives. Key Responsibilities Manage and support relevant internal and external clinical operations resources while also contributing to strategy, tactics, and driving execution of global clinical studies. Influence, manage and lead the planning, budgeting, and study management processes in global clinical studies. Accountable for oversight and management of CRO/vendor partners contracted to the study / region assigned Leads and supports the cross functional study team to successfully manage external service providers functional counterparts (including CRO(s), vendors and subcontractors), to ensure project deliverables are executed on time and within budget, whilst also taking on clinical trial management (CTM) role as needed. Leads/participates in clinical data review Contribute to the development and operational design, planning, and strategy of clinical trial protocols and study and development plans. Creates/supports scenario planning and risk benefit analyses to make recommendations to align with corporate strategies. Contribute to models of performance excellence by identifying best practices, reviewing measurement systems and improving operational efficiency in department. Manage relationships with vendor partners and suppliers in clinical programs to optimize delivery. Ensures efficient and effective communication and exchange of information across projects and reporting functions. May participate in Clinical submission activities. Supports the development and implementation of department level SOPs for clinical trials and related activities. Interface with departments within and outside of Dianthus including Finance, Regulatory, Quality, and Tech Ops. Represent the company at Investigator Meetings. Other such duties as may be determined or assigned. Experience Requires a minimum of Undergraduate (Life Sciences preferred) degree, RN degree, or equivalent. Advanced degree desirable. Experience in the pharmaceutical or biotechnology industry as a clinical research professional, including successful clinical trial management role and hands-on managerial experience executing high quality clinical trials from inception to completion. Excellent knowledge of international regulatory and ICH GCP guidelines. Experience in clinical trial management and managing high-functioning clinical trial project teams. Demonstrated ability to manage large complex budgets. Experience and understanding of the drug development process, clinical development planning and clinical trial execution. Understanding of clinical aspects of therapeutic area along with willingness to develop in-depth expertise. Experience using computer applications including spreadsheets, email, word-processing software & web-based systems (EDC, IVR/IWRS, CTMS). Ability to work well independently as well as a member of multiple, integrated teams. Ability to contribute creative yet practical solutions to problems. Ability to multi-task and manage several projects in parallel while paying attention to detail. A wide degree of creativity and latitude is expected. Ability to travel up to 30%.
$75k-116k yearly est. Auto-Apply 60d+ ago
Clinical Trial Manager
Sejelas
Remote job
We are seeking to recruit an experienced Clinical Trial Manager for a biotechnology company developing novel therapies for genetic cardiomyopathies. Reports to: Head of Clinical Operations Some of the responsibilities include: Manage the day-to-day planning, execution, and delivery of early-phase (Phase I and II) clinical trials in compliance with ICH-GCP guidelines and SOPs. Oversee trial timelines and budgets to ensure studies are completed on schedule and within financial parameters. Assessing risks and implement mitigation plans during the trial Manage site feasibility, selection, initiation, monitoring, and close-out activities for global studies. Collaborate with cross-functional teams to ensure trial priorities are clearly communicated and executed. Support the development and refinement of departmental SOPs, guidelines, procedures, and Qualifications Bachelor's degree (or equivalent) required. 5+ years of relevant experience, at least 3 years of study management experience in a biotech. Hands-on experience managing clinical trials in the EU and/or US. Prior experience in managing FIH gene therapy trials is required. Excellent communication, project management, and organization skills. Flexibility and ability to prioritize and manage multiple tasks in a challenging environment. Excellent written and oral communication skills; fluency in English as a business language. Ability to travel (up to 25% time) internationally
$75k-116k yearly est. 60d+ ago
Clinical Research Scientist Interventional Solutions
Gehc
Remote job
SummaryAre you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionResponsibilities Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities. Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions). Support adoption of new technology or clinical applications through advocacy and evidence. Participate in customer presentations regarding use of Interventional products for institution research purposes. Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs. Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns. Grow technology leadership mindshare through joint scientific presentations and publications. Install/upgrade research equipment and software & prototypes Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products. Study new technology concepts and leverage expertise to move initiatives forward. Note: No sponsorship available for this role now or in the future to work in the United States.. Qualifications PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field. 3+ years of experience in Interventional healthcare industry or research. Knowledge of Interventional procedures, anatomies, clinical practice. Excellent written and verbal communication skills. Excellent customer relationship management and collaboration skills. Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas. Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task. Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. Able to individually lead complex projects with autonomy, rigor, drive & competence Ability to travel ( Quality, Compliance, and Continuous Improvement focus Desired Characteristics 5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics. Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) Demonstrated record of innovation and development. History of publications, clinical/non-clinical experiments, knowledge in statistics Programming / Image processing experience Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. #LI-BR3 #LI-Remote We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: No
$97.6k-146.4k yearly Auto-Apply 42d ago
Senior Clinical Trial Associate
Apogee Therapeutics
Remote job
About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading! Role Summary We are seeking a Sr. Clinical Trial Associate (Sr. CTA) role, who will support 1-3 project teams. In this role you will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct and close-out. This may include creation of study documents, implementing and maintaining trackers, coordinating vendor payments and supplies to research units, performing quality control of clinical trial documents and assisting with study start-up contracting and study coordination activities. This role will also have accountability for managing the collection, review, completeness, and quality of their assigned eTMFs. Key Responsibilities Act as a central contact for the cross-functional study team for designated project communications, correspondence, and associated documentation Maintain and perform QC reviews on study specific electronic Trial Master Files to ensure inspection readiness and compliance with applicable regulations and Good Clinical Practices Track and report study metrics; inclusive of start-up, data management, and contracting as needed Participate in GxP audits and related clinical compliance activities Prepare and track study documents (e.g., contracts, budgets, IRB documentation) Maintain databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, and clinical data or sample flow, etc.) and assist in ensuring all systems, including but not limited to, EDC (Data Management), eTMF, CTMS, Payments, etc. are best utilized per Quality standards Administer user access and change control within Apogee's electronic systems Assist in User Acceptance Testing for all EDC needs in regard to Data Management and all Clinical Systems Assist with vendor management and associated logistics, as assigned Contribute to the creation of presentations, as needed for project, departmental, sponsor and/or business development presentations Collaborate with Clinical Project Manager, Clinical Supply Unit and QA in order to manage activities related to Clinical Supplies. Manage study related payment procedures. Interact with external providers during study conduct (CROs, monitors and, occasionally, with investigators and Hospital personnel). May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training. Organize and/or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information Assist in creating and implementing departmental procedures Assist with information gathering, literature searches, and creation of presentations, as needed Responsible for managing team training assignments and oversight/ownership of due dates to support compliance Ideal Candidate BS/BA in Life Sciences or equivalent 4+ years of experience in similar position in Biotech, Pharmaceutical or CRO industry and in R&D environment Extensive experience with TMF, including set-up, maintenance, QC/ QR and query management. Familiar with DIA reference model Knowledge of ICH/GCP and applicable regulations Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global) Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail and responding to rapidly changing priorities and aggressive deadlines Proficient in MS Office (Word, Excel, Project), Adobe, SmartSheet, and ISI Toolbox Strong critical thinking, organizational and time-management skills Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient and Egoless Position requires up to 15-20% travel,including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences. The anticipated salary range for candidates for this role will be $130,000 - $145,000 per year.The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. What We Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave Commitment to growing you professionally and providing access to resources to further your development Apogee offers regular all team, in-person meetings to build relationships and problem solve E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster. A pogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. To review our privacy policy, click here It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
$130k-145k yearly Auto-Apply 15d ago
Manager, Clinical Trials Education
Dana-Farber Cancer Institute 4.6
Remote job
This position's work location is remote with occasional time onsite as needed. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI). The Office of Data Quality (ODQ) provides research support to the Dana-Farber/Harvard Cancer Center with a focus on quality assurance, quality control, and process improvement. Functions of ODQ include protocol subject registration and randomization, clinical research auditing, data and safety monitoring, quality control of DF/HCC initiated clinical trial data, national protocol and investigator registrations, clinical trials education, and committee management. The Clinical Trials Education Manager reports to the Director of ODQ. The Clinical Trials Education Manager is responsible for supervising and overseeing the centralized clinical research educational activities and resources for research staff of the Dana-Farber/Harvard Cancer Center (DF/HCC). The cancer center is made up of the Boston-area, Harvard-affiliated institutions including: Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, Boston Children's Hospital, and Massachusetts General Hospital. Major responsibilities of the role include managing projects for and ensuring oversight over ODQ staff who coordinate the following activities: identifying educational needs for the consortium, production of educational materials and resources, conduct of live and online educational sessions, development and management of DF/HCC Policies and Operations, ODQ communications and website resources, and customer service for research staff and physician questions regarding DF/HCC policies and education requirements. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. Responsibilities * Chair the DF/HCC Education Subcommittee * Identifying appropriate representatives from DF/HCC member institutions * Managing committee meetings, agendas, and documentation * Working with the committee to identify educational needs and opportunities, and develop education resources in response to those needs * Oversight of education-related projects and delegation/distribution of project work amongst the committee members * Conduct of live educational activities for DF/HCC clinical research staff, including: * Scheduling topics and speakers for DF/HCC live training sessions * Recording and posting the training sessions for future viewing * Overseeing staff who coordinate meeting logistics (location, AV requirements, etc.) * Reporting metrics and statistics to the ODQ Director and senior DF/HCC leadership * Oversee the development, review, and approval process of the DF/HCC Policies and Operations, which includes the following: * Management of the Clinical Research Operations Subcommittee (CLINOPS) operations and documentation, including approval of policy decisions * Presenting feedback and recommendations from the research community and Education Subcommittee; recommending policy changes, and draft policy writing * Distribution of draft policies for comment, collection of feedback, policy document cleanup and finalization and routing policies for approval sign off * Maintaining version history of policies and operations * Announcing policy changes to the DF/HCC community and posting revised policies and operations on the DF/HCC website * Providing background or template training materials to institutional clinical trial offices to support implementation of policy changes * Developing and maintaining e-learning modules for DF/HCC required trainings and additional topics based on need. * Designing, creating, recording, and updating e-learning modules for posting to the DF/HCC website. * Ensuring training resources are updated with regulatory/policy changes. * Identifying where additional modules are needed and promoting existing educational materials * Administration of the DFCI CITI training program account * Management of the institutional CITI account * Tracking completion of required CITI training and notifying research staff whose training has lapsed or is missing * Ensure compliance with investigator annual NCI registration requirements * Oversight of ODQ staff who provide direct support to investigators with submitting registration materials in the NCI RCR system * Responsible for tracking and reporting to leadership on compliance with registration requirements and deadlines; provide proactive notifications and reminders * Escalate non-compliance to institutional clinical trials offices, institutional leaders, and CLINOPS as needed * Act as the face of ODQ for DF/HCC communications * Sending broadcast announcements as needed, including for important updates, changes, and to promote educational resources * Overseeing and curating ODQ's online presence, resources, and educational materials on the DF/HCC website * Ensuring excellence in customer service to investigators and study teams. Oversees staff who are responsible for email communications in the ODQ Education mailbox Qualifications * Bachelor's degree (BA, BS) in life sciences, nursing, or other health related discipline is preferred. * 5 years of experience in clinical trials; oncology experience preferred * 2 years of experience supervising projects and/or staff. * Expert knowledge of federal regulations regarding human subject research protections, FDA and ICH Good Clinical Practices. Pay Transparency Statement The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications. For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA) $99,900 - $116,200 At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law. EEOC Poster
$99.9k-116.2k yearly Auto-Apply 26d ago
CT Clinical Study Manager
Philips Healthcare 4.7
Remote job
Job TitleCT Clinical Study ManagerJob Description Clinical Study Manager, Computed Tomography (EST Time zone) The Clinical Study Manager will be responsible for the execution and regulatory compliance of clinical studies for our Computed Tomography business. Your role: Manages and executes clinical studies with strict adherence to protocols, regulatory standards (ISO, GCP, FDA), and Philips procedures, ensuring data accuracy, integrity, and effective handling of deviations. Provides expert guidance and support to study sites and investigators on regulatory requirements, protocol adherence, and Good Clinical Practice, while reviewing study documentation for completeness and compliance. Enhances and streamlines clinical research processes through continuous data review, process optimization, and proactive resolution of queries and discrepancies related to study conduct and regulatory compliance. Collaborates and communicates effectively with internal cross-functional teams and external partners, facilitating alignment, issue resolution, and achievement of project objectives throughout the study lifecycle. Monitors study progress, milestones, and budgets, conducts trend analysis for risk mitigation, and delivers timely study updates and recommendations to leadership and senior management. You're the right fit if: You've acquired 3+ years of related experience in clinical research execution in the medical device industry. Experience using EDC, CTMS, and eTMF systems is highly preferred. Your skills include profound knowledge of clinical research process legislation and ICH-GCP guidelines. You have a Bachelor's/master's degree or higher in Life Sciences or an equivalent field. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. You demonstrated strong analytical, project management, and communication skills; thrive in cross-functional environments, and are committed to maintaining high standards of data integrity and regulatory compliance. Must be willing to travel up to 50% globally to study sites, based on business needs. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is a field-based role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details The pay range for this position in AL, FL, GA, MI, NH, NC, OH, PA, VT, VA, WI is $101,250 to $162,000. The pay range for this position in DE, MD, RI, is $106,313 to $170,100. The pay range for this position in CT, MA, NJ, NY, DC, is $113,400 to $181,440. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. #LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
$113.4k-181.4k yearly Auto-Apply 14d ago
Clinical Trial Manager (Contract)
Allogene Therapeutics, Inc. 3.6
Remote job
About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit ***************** and follow @AllogeneTx on X (formerly Twitter) and LinkedIn. About the role: The Clinical Trial Manager (CTM) is responsible for the management of clinical trials from study start-up activities through the clinical study report. The CTM drives completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates, and resolves clinical study operational issues; and participates in process improvement initiatives as required. This is a 6-month contract opportunity with the possibility of extension or contract-to-hire. Responsibilities include, but are not limited to: * Manage all clinical aspects of study under oversight of Clinical Operations senior management including initial operational feasibility, study timelines, budget and metrics; study document development and review (training documentation, ICF, study specific plans, eCRF Guidelines, lab and radiology manuals, etc.), plans and manages study-specific meetings (e.g., Study Team Meetings, Investigator meetings, etc.). * Interface with cross-functional teams as Clinical Operations regional or global study lead (e.g., Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors and Investigators/site staff). Work cross-functionally and with external vendors to proactively manage the execution of the clinical trial. * May oversee clinical trial execution in one or more regions within a global clinical trial. * Review protocol and amendment development, Informed Consent Forms, clinical trial-related training, and Site Study Tools * Ensure clinical trial execution in compliance with the protocol and ICH/GCP guidelines/regulations, including the review of monitoring reports, protocol deviations, and eTMF * Partner with Clinical Quality Assurance to follow through on corrective and preventative actions (CAPA) identified during internal and external audits * Vendor oversight: effectively communicate expectations to CRO, ensure appropriate site management, hold CRO accountable to timelines, and verify quality metrics * Provide study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel. * Manage study budget; review and approve clinical invoices against approved scope of work and budget, evaluate and approve vendor change orders, coordinating review of updates or revisions with key cross-functional partners, as necessary. * Prepare and present project debriefings to Clinical Operations management. * Provide study-related guidance and leadership to internal and external partners, as appropriate. Position Requirements & Experience: * Bachelor's degree or equivalent combination of education/experience in science or health-related field with at least 3 years of clinical trial management experience in a Pharmaceutical/Biotech organization. * Clinical trial management experience as a contractor or employee of an industry sponsor * Vendor management * Robust understanding of ICH/GCP, and knowledge of regulatory requirements. * Strong clinical study/project management skills. * Excellent communication and organizational skills (ability to prioritize a number of tasks of varying complexity), along with problem solving, conflict resolution, leadership and team-building skills. * Candidates must be authorized to work in the U.S. Preferred experience: * Prior clinical trial experience in oncology therapeutic development with an industry sponsor or Contract Research Organization * Multi-regional study management experience advantageous We offer a chance to work with talented people in a collaborative environment. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law. As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients. #LI-EL1 #LI-REMOTE
$91k-137k yearly est. 55d ago
Manager I, Clinical Trials
Tarsus Pharmaceuticals
Remote job
Let's talk about some of the key responsibilities of the role: Oversees and manages key study activities including study start-up, development of study plans, vendors, drug inventory, lab supplies, non-clinical study supplies, lab sample management, and screening and enrollment activity. Involved in the review of protocols, Case Report Forms (CRFs), investigator brochures, informed consent forms, and any other study-related documents as assigned; participates in user acceptance testing for eCRFs and recommends operational changes as required. Develops key study documents: training materials, site study materials, and related study documentation. Assists in the identification, selection, and site qualification processes of study sites. Ensures the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study; help train the study staff in conducting the study per GCP and in performing procedures per protocol. Arranges and oversees site visits. When monitoring has been delegated to a CRO, provides Sponsor oversight of monitoring activities. Organizes and makes presentations at site initiation visits and/or Investigator Meetings. Manages and tracks all drug supply inventory (e.g., storage, distribution, site inventory, etc.) and updates supply tracking with projection vs usage. Reviews study budgets and tracks, processes, and manages vendor invoices in support of study financial tracking. Assists in the creation of project tools, tracking tools, etc. to report and oversee study specific metrics as needed. Reviews and assists in the preparation of Clinical Study Reports (CSRs). May serve as a resource for others within the company for clinical trials management expertise. Factors for Success: Bachelor's degree (life science preferred) and five years clinical experience or Associate's degree and 7 years clinical experience. Minimum of 2 years of clinical research experience at a Pharmaceutical, Biotech, or CRO company. Experience managing outside vendors (e.g., CROs and labs). Thorough knowledge of ICH/GCP R2 Guidelines and working knowledge of health authority requirements and regulations. Demonstrated ability to attain and maintain a working knowledge of applicable Standard Operating Procedures at Tarsus and with CRO/vendors. Ability to work independently as well as collaboratively in an efficient manner. Skillful in prioritizing workflow with different demands to meet deadlines in an accurate and timely manner. Flexibility to adjust to changing needs in the Clinical Department and organization. Excellent knowledge of MS Office, Excel, and PowerPoint Strict attention to detail. A Few Other Details Worth Mentioning: The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. Remote work is an option. We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact! This position reports directly to our Associate Director, Clinical Operations. Some travel may be required - up to 20% At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $93,700 - $131,300 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: ************************************************ #LI-Hybrid #LI-Remote Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
$93.7k-131.3k yearly Auto-Apply 12d ago
Clinical Trial Mid-Level Project Manager
Vitalief
Remote job
Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role Vitalief is seeking a highly organized and detail-oriented Mid-Level Project Manager to provide operational oversight and coordination for our client's Pediatric Acute Leukemia clinical trials. This full-time, fully benefited role serves as the primary liaison between the pharmaceutical clinical research team and CROs, ensuring trials are executed efficiently, on budget, and in compliance with regulatory standards. The Project Manager bridges scientific and operational aspects of clinical research, leading cross-functional teams to deliver high-quality studies evaluating the safety and efficacy of pharmaceuticals. WHY VITALIEF? Contribute to advancing scientific discoveries that improve patient lives. PEOPLE FIRST culture with opportunities for growth and innovation. Competitive benefits include 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans. Salary Range: $70,000 to $80,000 (commensurate with experience). Work Location: 100% Remote (seeking only candidates that live in the EST Zone). KEY RESPONSIBILITIES Trial Planning and Initiation Support bid strategies and contract discussions with CROs, including site selection and patient enrollment. Review and finalize trial protocols and related documents. Build project plans, timelines, and vendor assessments. Establish and maintain collaborative relationships with sponsors, CROs, vendors, investigators, and site staff. Trial Execution and Management Monitor study activities for compliance with protocols and regulatory requirements. Identify potential delays or out-of-scope work and implement mitigations. Manage study risks and escalate issues to leadership as needed. Oversee study documentation, including case report forms, drug records, and regulatory filings. Motivate team members and investigators to achieve trial objectives. Stakeholder Management Maintain regular communication with sponsors and internal teams. Conduct status meetings and provide updates to leadership and stakeholders. Develop realistic budgets and timelines. Quality and Compliance Ensure audit readiness and compliance with ICH/GCP, FDA, IRB/IEC, and SOP requirements. Review monitoring reports and support development of study materials, processes, and committees. Anticipate and mitigate project risks. QUALIFICATIONS Education and Experience Bachelor's degree in life sciences, nursing, pharmacy, medical sciences, or related field preferred. 5 or more years of clinical research experience, including oversight of multicenter or complex studies; oncology experience highly preferred. 2 or more years of experience in a clinical trials oversight capacity as a project manager, ideally working for a sponsor or a CRO. Project management certification (CCPM or PMP) preferred. Knowledge of clinical trial practices and project management principles. Strong organizational, communication, and interpersonal skills. Ability to manage multiple projects, deadlines, and budgets effectively. Proven leadership and collaboration skills in multi-level team settings. Problem-solving and decision-making abilities in fast-paced, dynamic environments. PHYSICAL DEMANDS: Prolonged periods sitting working on a computer, standing, walking, visual perception, talking and hearing. Lifting up to 20lbs.
$70k-80k yearly Auto-Apply 60d+ ago
Sr. Clinical Trial Associate
Allen Spolden
Remote job
The remote -based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. Provide support for essential daily clinical study activities, including regulatory inspection readiness, following established protocols under the general management of the CTA Manager. Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model. Perform departmental tasks. Perform developmental tasks with oversight of CTA Manager. ACCOUNTABILITIES: For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including: Approval of study documentation, including essential document packets, study plans, informed consent forms, etc. Support oversight of risk -based monitoring. Attend important team meetings. Support regulatory inspection readiness (e.g. preparation of materials and participation during regulatory inspections.) Support additional ad -hoc activities, as agreed with CTA Manager. Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors. Escalate clinical trial insurance issues. Support Health Care Provider Engagement for facilitating contracts and meetings. Support vendor contract administration. Requirements Bachelor's degree or equivalent international degree. 5 or more years' experience in pharmaceutical industry, clinical research organization, or related role. Experience in Phase 2 and 3 studies and global/international studies is advantageous. Experience working across multiple therapeutic areas is advantageous. Knowledge in global regulatory and compliance requirements for clinical research. Excellence in task management and collaboration. Requires availability for 5 -10% domestic and international travel, including overnight and international travel on an as -needed basis. Benefits 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs
$73k-122k yearly est. 60d+ ago
Clinical Trial Contracts Associate I
Stratacuity
Remote job
Clinical Trials Contracts Associate I (Remote) Rate: $25-$30/hour | Fully Remote We are seeking a Clinical Trials Contracts Associate I to join our team and support the contracting process for clinical trials. This role is fully remote and involves both frontline and backend administrative duties to ensure smooth and compliant contract operations. Key Responsibilities * Contract Administration: Review, process, and maintain clinical trial contracts and related documentation. * Collaboration: Work closely with clinical research teams, sponsors, and site staff to facilitate negotiations. * Communication: Serve as a point of contact for stakeholders, providing updates on contract status. * Process Improvement: Identify opportunities to streamline workflows and enhance efficiency. * Contract Reconciliation: Research discrepancies, track pending agreements, and support execution steps. Qualifications * Education: Bachelor's degree in business, healthcare, or life sciences. * Experience: 1-3 years in contract administration, clinical trials, or related field preferred. * Skills: Strong attention to detail, organizational ability, and excellent verbal/written communication. * Problem-Solving: Ability to identify issues and propose solutions in a fast-paced environment. Why Join Us This role offers the opportunity to contribute to the success of clinical research initiatives while working remotely. You'll play a vital part in ensuring contractual obligations are met and supporting teams that advance healthcare innovation. Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click here for more details. Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide. Employee Type: Contract Remote: Yes Location: Memphis, TN, US Job Type: Scientific and Clinical Date Posted: December 11, 2025 Pay Range: $25 - $30 per hour Similar Jobs * Sr. Clinical Study Associate III * Senior Contracts Analyst * Warehouse Associate * Warehouse Associate * Development Associate
$25-30 hourly 1d ago
Clinical Trial Management Associate
Ionis 4.6
Remote job
Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! CLINICAL TRIAL MANAGEMENT (CTMA) SUMMARY: The Clinical Trial Management Associate (CTMA) works as part of the Study Management Team to contribute towards the successful management and execution of clinical trials. RESPONSIBILITIES: Conducts study tracking (e.g., CTMS, start-up, milestone, close-out); generates, reviews and distributes management reports from internal tracking systems at requested intervals Collaborates with the Clinical Trial Manager and/or the Clinical Project Lead on the development of certain study-specific plans and/or processes Presents at team meetings as needed (i.e., Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training, etc.) Collects and reviews essential documents from Investigational sites Supports TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents Participates in study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation Contributes to the development of the Monitoring Plan and assists with ensuring appropriate quality and timely monitoring of clinical sites Assists in development of study materials, case report forms (CRFs), informed consent documents for clinical studies Works with internal and external team members (i.e. Clinical Supplies, Toxicology PK, Regulatory Affairs, Clinical Data Management and CRO/Vendors) to deliver high quality trial execution Prepares investigational site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.) Acts as primary contact for study contractors (e.g., contract CTMs, field CRAs) Keeps the Clinical Project Lead (CPL) informed of the progress of projects Develops and maintains good working relationships with Investigators and study staff Assists in the organization and preparation of and participates in Investigator Meetings (as applicable) Performs document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, invoices, and other study documentation Executes meeting logistics (e.g., schedule meetings, distribute meeting agendas and minutes), as needed Ensures timely study entry and updates to ClinicalTrials.gov Assists with design and preparation of study related materials for the training of internal and external staff Participates in co-monitoring activities and oversight of CRO or contract CRAs for pre-study, initiation, routine monitoring, and closeout visits Assists with the tracking and management of study specific budgets Participates in development of departmental processes, SOPs, and initiatives Assists with facilitating resolution of data queries and requests from Clinical Data Management Travel is variable and estimated at 20% COMPETENCIES IDENTIFIED FOR SUCCESS: Ability to work in a team or independently as required Effective written and verbal communication skills Critically evaluates job tasks and the impact on overall trial management objectives Sound problem-solving capabilities Good judgment in triaging issues from internal and external customers Effectively collaborates with Clinical Trial Team members Outstanding organizational skills with the ability to multi-task and prioritize Exceptional attention to detail Proven flexibility and adaptability REQUIREMENTS: Bachelor's Degree preferred Minimum of two (2) years in clinical research or healthcare related industry, or equivalent combination of education and experience; site monitoring experience a plus Experience in scientific discipline and multiple therapeutic areas preferred Experience/training in the following areas: GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process Proficiency in MS Office including Word, Excel, and PowerPoint Please visit our website, ******************** for more information about Ionis and to apply for this position; reference requisition # IONIS003866 Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits Full Benefits Link: ************************************************************************************************************************ The pay scale for this position is $84,240 to $118,308 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
$84.2k-118.3k yearly 60d+ ago
Clinical Study Manager-Remote(Job Id- 3908-1)
Artech Information System 4.8
Remote job
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The Study Specialist will augment activities performed by existing study team members whether from client or client's preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. • This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development. • Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety. Organizational Relationships: • Oversight by client Clinical Operations Study Team Lead • Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur • Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead) Primary Duties: • Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff • Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes • Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites • Point of escalation for clinically identified site related issues • Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee • Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support) • Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality • Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file • Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client • Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training. • Complies with all departmental objectives and metrics related to study execution • Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge Secondary Duties • As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs • As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution • Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study • Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan Training and Education Preferred: • Bachelor's Degree in Life Science, RN preferred • Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring • Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinical trials highly desirable) • Demonstrated ability to problem solve and to prioritize site related activities • Demonstrates solid understanding of drug development and clinical practices • Understands and is able to comprehend study protocols • Has knowledge of FDA regulations • Possesses working knowledge of GCPs and other regulations governing clinical research • Demonstrates technical expertise in computer skills • Demonstrates diligent and self-motivated approach to working in an independent environment • Demonstrates effective oral and written communication skills • Travel anticipated at 25% but could up to 50% at times. Qualifications BS/MS Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960
$66k-97k yearly est. 1d ago
Clinical Research Associate- Remote
Icon Plc 4.8
Remote job
Clinical Research Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing * Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. * Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. * Collaborating with investigators and site staff to facilitate smooth study conduct. * Performing data review and resolution of queries to maintain high-quality clinical data. * Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile * Bachelor's degree in a scientific or healthcare-related field. * Minimum of 2 years of experience as a Clinical Research Associate. * In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. * Strong organizational and communication skills, with attention to detail. * Ability to work independently and collaboratively in a fast-paced environment. * Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply
$48k-70k yearly est. 50d ago
Cancer Clinical Research Manager - GI Oncology (Hybrid)
Stanford University 4.5
Remote job
Stanford Cancer Institute - Clinical Trials Office - Clinical Research Manager - GI Oncology (Hybrid Work Schedule) The Stanford Cancer Institute (SCI) was re-designated as a comprehensive cancer center by the NCI in early 2022, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University. We seek a Clinical Research Manager for GI Oncology to help us enact our mission to reduce cancer mortality through comprehensive cancer research, treatment, education, and outreach programs. Given the SCI's mission, breadth, and depth, we thrive in a fast-paced, team-oriented, and forward-thinking environment, employing over 375 staff with tremendous opportunities for personal and professional growth. The Clinical Trials Office (CTO) is an integral component of the SCI. This vital work enables our adult and pediatric cancer centers to translate research from the laboratory into clinical settings. You will be working with a world-class community of faculty and staff who are fundamentally changing the world of health care in the cancer arena. Reporting to an Associate Director of Clinical Research, the Clinical Research Manager (CRM) GI Oncology will support cancer clinical research focused in oncology. The CRM will be conversant in the goals, mission, and priorities of the Institute and utilize this knowledge to conduct impactful clinical research focusing on high quality and efficiency. We are seeking candidates with excellent organizational skills, attention to detail, and a willingness to learn. Candidates must be eager to take on challenges with a high degree of professionalism, initiative, and flexibility. Responsibilities include working with the research team, clinical staff, and Stanford Health Care departments to support safe and compliant clinical research. Duties include*: * Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators. * Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures. * Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel. * Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required. * Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions. * Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group. * Lead or chair committees or task forces to address and resolve significant issues. * Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences. * Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance. * Assist with analysis of data and preparation of manuscripts and scientific presentations. * - Other duties may also be assigned. DESIRED QUALIFICATIONS: * Clinical research certification. * Previous experience in oncology, specifically GI oncology. * Experience with clinical trial finance management. EDUCATION & EXPERIENCE (REQUIRED): Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): * Excellent interpersonal skills. * Proficiency in Microsoft Office and database applications. * Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. * Knowledge of medical terminology. * Demonstrated managerial experience. CERTIFICATIONS & LICENSES: Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. PHYSICAL REQUIREMENTS*: * Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. * Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. * Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. * - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS: * Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. * May require extended or unusual work hours based on research requirements and business needs. WORK STANDARDS: * Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. * Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. * Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, ******************************* The expected pay range for this position is $124,521 to $153,615 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (***************************************************** provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process. Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. Additional Information * Schedule: Full-time * Job Code: 4926 * Employee Status: Regular * Grade: J * Requisition ID: 107873 * Work Arrangement : Hybrid Eligible
$124.5k-153.6k yearly 22d ago
Clinical Research Associate (PhD Candidates)
Medpace 4.5
Remote job
Join our CRA Team in Cincinnati, Ohio! The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with PhD/Life Science backgrounds who want to explore the research field, travel the US, and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you! MEDPACE CRA TRAINING PROGRAM (PACE ) No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence: * PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA. * PACE will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums. * To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process. WHY BECOME A CRA This role takes you on a journey through travel and excitement which will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. The CRA position provides many other distinctive advantages including: * Dynamic working environment, with varying responsibilities day-to day * Expansive experience in multiple therapeutic areas * Work within a team of therapeutic and regulatory experts * Defined CRA promotion and growth ladder with potential for mentoring and management advancements * Competitive pay and many additional perks unmatched by other CROs (SEE BELOW). WE OFFER THE FOLLOWING * Competitive travel bonus; * Equity/Stock Option program; * Training completion and retention bonus; * Annual merit increases; * 401K matching; * The opportunity to work from home; * Flexible work hours across days within a week; * Retain airline reward miles and hotel reward points; * Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere; * In-house travel agents, reimbursement for airline club, and TSA pre-check; * Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more; * CRA training program (PACE ); * Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts; * In-house administrative support for all levels of CRAs; and * Opportunities to work with international team of CRAs. Responsibilities * Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; * Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; * Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; * Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; * On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward; * Verification that the investigator is enrolling only eligible subjects; * Regulatory document review; * Medical device and/or investigational product/drug accountability and inventory; * Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; * Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and * Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Qualifications * Must have a minimum of a Bachelor's degree in a health or life science related field; * Ability to travel 60-70% to locations nationwide is required, or less if remote/virtual visits required; * Must maintain a valid driver's license and the ability to drive to monitoring sites; * Minimum 1 year healthcare-related work experience preferred; * Proficient knowledge of Microsoft Office; * Strong communication and presentation skills; and * Must be detail-oriented and efficient in time management. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
$49k-80k yearly est. Auto-Apply 60d+ ago
Clinical Research Associate/Coordinator I
Brigham and Women's Hospital 4.6
Remote job
Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. GENERAL SUMMARY/ OVERVIEW STATEMENT: The Translational Clinical Research Associate/Clinical Research Coordinator works under general supervision to consent and enroll eligible patients to clinical translational research protocols and manage all aspects of data collection and requests. In particular, the CRA/CRC I will work on specimen collection studies. The Translational CRC/CRA will work closely with multiple providers to support their translational research projects. The CRA/CRC I will be trained on the institutional and federal regulations governing clinical research. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact. This is an on-site/hybrid position. Duties will be performed primarily on-site in ambulatory/clinical office setting. Components of the data/regulatory role may allow for remote work. Job Summary PRINCIPAL DUTIES AND RESPONSIBILITIES: All duties will be performed under general supervision by the Clinical Research Manager. The following clinical duties will be performed: * Interfacing in a professional manner with a diverse team of physicians, clinical research assistants, research nurses, pathologists and patients * Coordinating the collection and processing of tissue samples and blood samples from patients * Consent patients to translational research studies (minimal risk specimen collection studies) * Explain study protocol to patients and obtain informed consent * Screen and follow patients relevant to specific projects/studies * Assist clinical team in screening potential patients for study participation * Schedule all protocol required tests and procedures * Consent patients to specimen collection protocols * Coordinate patient appointments with physicians, nurses, and all test areas * Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers * Prepare pre-visit communication for providers to ensure required assessments are completed and documented * Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation * Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition * Coordinate, obtain, process, and ship protocol required blood and tissue samples * Ensure collection and processing (e.g. spin/separate/freeze) of all required correlative research blood samples with the coordination of the MGH Sample Processing Lab (SPL) The following data management responsibilities will be performed: * Collecting detailed clinical and treatment information on patients who are undergoing genetic testing, receiving treatments for cancer, or are enrolled in a research study * Maintaining an updated and organized database of patients * Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria * Enroll patients as required by the study sponsor and internal enrollment monitor team * Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance * Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements. * Maintain research charts and/or electronic files for all enrolled patients * Ensure adequate source documentation is in place for all data reported * Resolve data queries issued by the sponsor * Obtain protocol clarifications from the study sponsor and communicate information to the research team * Facilitate the request and shipment of samples * Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies * Assist in abstracts, presentations, and manuscripts The following regulatory duties may be performed: * Assist with new study submission * Assist with updates and/or changes to current studies * Maintain and organize study specific regulatory binders * Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB * Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study * Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required * Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process * Collect, complete, and submit essential regulatory documents to various regulatory entities * Ensure appropriate documentation of delegation and training for all study staff members * Maintain screening and enrollment documentation * Prepare monthly enrollment and data summary for study team SKILLS/ABILITIES/COMPETENCIES REQUIRED: * Ability to be self-motivated to work independently and as a team member * Analytical skills and ability to resolve problems * Careful attention to detail * Excellent organizational skills * Ability to follow directions * Excellent verbal and written communication skills * Computer literacy * Working knowledge of clinical research protocols * Ability to demonstrate respect and professionalism for subjects rights and individual needs Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Clinical Research or compliance experience 1-2 years preferred Knowledge, Skills and Abilities * Ability to work independently and as a team member. * Analytical skills and ability to resolve problems. * Ability to interpret acceptability of data results. * Careful attention to detail. * Good organizational and communication skills. * Working knowledge of clinical research protocols. Additional Job Details (if applicable) WORKING CONDITIONS: * Duties will be performed primarily on-site in ambulatory/clinical office setting * Components of the data/regulatory role may allow for remote work. Remote Type Hybrid Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
$19.8-28.4 hourly Auto-Apply 20d ago
Senior Clinical Trial Specialist - Remote Position
Puma Biotechnology, Inc. 4.3
Remote job
The Senior Clinical Trial Specialist (Sr. CTS) is responsible for providing operational support for the day-to-day execution of clinical trials, following established SOPs, GCP and applicable regulatory requirements in the execution of all activities; proactively identifying and resolving operational project issues; and participating in process improvement initiatives as required. Major Duties/Responsibilities * Ensures timely and accurate study-related communication to clinical personnel (eg, internal and external study teams, consultants and investigative site personnel); prepares and disseminates clinical trial correspondence, newsletters, and IND safety letters (working with project clinician); and assists with the creation of study-specific manuals, tools, and templates * Participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; acts as liaison between vendors and sites (eg, assists sites with laboratory sample queries) * Coordinates specified clinical trial meetings (eg, investigator meetings, study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes * Sets up, tracks, collects and maintains audit-ready clinical trial documentation and study status in an electronic system; manages and tracks regulatory/IRB/IEC documentation, IND safety letter distribution, confidentiality disclosure agreements, and other clinical trial documents; performs initial QC of electronic data feeds; generates, reviews and distributes reports; assists with quality assurance audits and resolution of audit findings * Participates in study design and execution by contributing operational experience and expertise: provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; posts and maintains study-related information on external websites when applicable * Ensures that necessary study supplies are available as per study timelines: sources clinical trial supplies through external vendors (eg, case report forms, study manuals, lab kits); manages, reviews and tracks drug shipment, destruction, and return; coordinates internal lab sample supply set-up and shipment * Maintains ongoing communication with site staff to resolve issues (eg, data queries, study management), support the staff, oversee the efficient conduct of the trial, and ensure continued compliance * May also be responsible for acting as a central point of communication between Puma and investigative sites for all assigned clinical trial-related activities to assure trials are conducted on time and budget, while fully compliant with ICH GCP and the SOPs in effect. In this role, the Sr. CTS may be responsible for: * Conducting on-site visits consistent with the applicable Clinical Monitoring Plan and SOPs for site qualification, site initiation, routine monitoring, site close-out and other site visits (eg, booster), as requested * Overseeing site recruitment, implementing appropriate contingency plans, as needed * Assessing site performance and conducting training/re-training when necessary to ensure site compliance with the protocol, applicable regulations and Puma expectations * Writing confirmation letters, follow-up letters and site visit reports that conform with guidelines and timelines stated in the applicable Clinical Monitoring Plan and SOPs * Mentors more junior staff * Manages study team meetings in absence of Clinical Trial Manager * Performs other tasks, as assigned by the manager/designee to promote the efficient conduct of the trial Skills & Abilities * Clear and timely communication, both written and verbal * Ability to handle a moderate volume of highly complex tasks within an established timeframe * Strong organizational skills and ability to prioritize * Ability to build relationships within the team, across departments, and with external contacts (eg, vendors, site staff) * Proactively identify and resolve/escalate project-related operational issues * Ability to work independently on routine assignments, and take over new assignments based on previous experience * Familiarity with word processing, spreadsheet and document management systems Travel Travel required up to 25%. Education & Professional Experience Required: * Bachelor's degree or equivalent combination of education/experience, preferably in science or a health-related field * Strong understanding of GCP, ICH and knowledge of regulatory requirements * Minimum one year prior Clinical Trial Specialist experience or commensurate Preferred: * One year of clinical research experience or health-related experience (eg, study coordinator, data management, nursing) * Completion of Puma Field Monitoring Course or equivalent, as required for field monitoring activities * Oncology experience * Global trial experience Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Physical Demands The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Compensation Range The salary range for this role is $90,000 - $100,000 per year. Higher compensation may be available for someone with advanced skills and/or experience. At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. #LI-Remote
$90k-100k yearly 13d ago

Learn more about clinical trial manager jobs

Work from home and remote clinical trial manager jobs

Nowadays, it seems that many people would prefer to work from home over going into the office every day. With remote work becoming a more viable option, especially for clinical trial managers, we decided to look into what the best options are based on salary and industry. In addition, we scoured over millions of job listings to find all the best remote jobs for a clinical trial manager so that you can skip the commute and stay home with Fido.

We also looked into what type of skills might be useful for you to have in order to get that job offer. We found that clinical trial manager remote jobs require these skills:

Patients
Clinical trial management
Clinical operations
Clinical research
Oversight

We didn't just stop at finding the best skills. We also found the best remote employers that you're going to want to apply to. The best remote employers for a clinical trial manager include:

Astellas Pharma
Amgen
Boston Scientific

Since you're already searching for a remote job, you might as well find jobs that pay well because you should never have to settle. We found the industries that will pay you the most as a clinical trial manager:

Pharmaceutical
Health care
Professional

Top companies hiring clinical trial managers for remote work

Most common employers for clinical trial manager

Rank	Company	Average salary	Hourly rate	Job openings
1	Amgen	$126,785	$60.95	8
2	Parexel International	$113,662	$54.65	290
3	THOR	$102,162	$49.12	0
4	QuintilesIMS	$94,609	$45.49	238
5	Boston Scientific	$93,457	$44.93	46
6	Astellas Pharma	$89,347	$42.96	0
7	Scripps Research	$86,499	$41.59	0
8	THRIVE	$86,326	$41.50	0
9	Drug Information Association	$86,049	$41.37	0
10	Allogene Therapeutics	$81,938	$39.39	3

Updated December 31, 2025

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Clinical Trial Manager remote jobs - 254 jobs

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