Clinical research director jobs near me - 206 jobs

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.

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

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%.

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

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 Title: Clinical Study Manager-Remote Location: Collegeville, PA Duration: 36 months Job Description: This position is needed to assist with Inspection Readiness Prepartion. The candidate will need to assist in leading diverse CRO teams through the Inspection Readiness process. Strong pTMF experience is also desired. A large component of the position will be to search for documents in pTMF and work with 2 different CRO to ensure that all documents are present in pTMF. Strong understanding of clinical trial documents is needed as well as a thorough understanding of a sponsor Inspection. The candidate should be flexible and able to positvely influence CRO staff while meeting the needs of the business. The candidate will also be asked to assist with filing protocol amendments in pTMF, ICD updates, and helping the COSTL and Clinican with tasks on an ad hoc basis. The candidate will lead 2 CROs through Inspection Readiness Activities for a large, high visibility, global oncology protocol that is in submission. The candidate needs to be able to influence and lead the 2 CROs through the Inspection Readiness checklist (~500 items). All items on the checklist will need to be reviewed, the location of the documents will need to be identified and entered onto the checklist. The candidate will need to be able to navigate through pTMF to ensure all documents are in pTMF in the correct cabinet and folder. The candidate will need to be proficient at searching for documents such as Monitoring Visit Reports, Financial Disclosure Documents, SOPs, vendor oversight plans. The candidate will need to compile a listing of relevant SOPs used on the study both past and present and download those SOPs into folders on a sharepoint space. The candidate will need to be comfortable leading 2 CROs in document retrieval and ensuring all Inspection Readiness Documents are up to date with the correct versions. The candidate will need to work with the 2 CROs for any corrections or updates needed. Additional Skills: pTMF, Inspection Readiness activities, Study conduct activities. Qualifications BS Additional Information For More information, Contact Best Regards, Akriti Gupta ************** Morristown, NJ 07960

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Essential Functions and Other Job Information: Essential Functions Monitors investigator sites with a risk-based monitoring approach; applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections. Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required. Qualifications: Education and Experience: Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 Months - 2 years as traveling clinical research associate). Valid driver's license where applicable. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Proven clinical monitoring skills Demonstrated understanding of medical/therapeutic area knowledge and medical terminology Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving Ability to manage Risk Based Monitoring concepts and processes Good oral and written communication skills, with the ability to communicate effectively with medical personnel Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues Good organizational and time management skills Effective interpersonal skills Attention to detail Ability to remain flexible and adaptable in a wide range of scenarios Ability to work in a team or independently as required Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software Good English language and grammar skills Good presentation skills Compensation and Benefits The salary range estimated for this position based in Nevada is $66,800.00-$122,400.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications: Bachelor's degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Ability to manage required travel of up to 75% on a regular basis US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Home Base Clinical Research Associate Level II & III Colombia Business Title Home Base Clinical Research Associate Level II & III Requisition ID EM-HB-SR-CRA-1005 Job Category Home Base Clinical Research Associate Job Description Description The experienced Senior Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA/EMEA/LA local guidelines, local regulations and ESTERN Medical Standard Operating Procedures. Conducts site visits to assess protocol and regulatory compliance and manages required documentation Responsible for ensuring that data will pass international quality assurance audits. Represents ESTERN Medical in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel. May assist project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team Requirements Education & Experience: * Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution Significant clinical research monitoring experience (comparable to at least 3-5 years) that provides the required knowledge, skills and abilities and experience mentoring or training others. * In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered. Knowledge, Skills and Abilities: * Effective clinical monitoring skills * Excellent understanding and demonstrated application of FDA/EMEA and local LA guidelines, Good Clinical Practices and applicable Standard Operating Procedures * Ability to mentor and train other monitors in a positive and effective manner * Ability to evaluate medical research data and proficient knowledge of medical terminology * Effective oral and written communication skills, with the ability to communicate effectively with medical personnel * Strong customer focus * Excellent interpersonal skills * Strong attention to detail * Effective organizational and time management skills * Proven flexibility and adaptability * Excellent team player with team building skills * Ability to work independently as required * Ability to utilize problem-solving techniques applicable to constantly changing environment. * Good computer skills: * Good knowledge of Microsoft Office and the ability to learn appropriate software * Good English, Spanish or Portuguese language and grammar skills

🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you. Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Summary Job Description THE IN-HOUSE CLINICAL RESEARCH ASSOCIATE (CRA) ROLE The Sr. In-house CRA is an important member of the Alira Health Clinical team. Sr. In-house CRAs manage and support clinical sites from site approval through close-out. Sr. In-house CRAs work closely with field CRAs and Clinical Project Managers to ensure the integrity of the trial data without the need for frequent travel. ESSENTIAL JOB FUNCTIONS Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), Investigator Site File (ISF) contents, etc. Supports sites in obtaining IRB approval, developing submission materials, and creating sitespecific ICFs Responds to sites' regulatory board requests for protocol and ICF clarification as needed Ensures all required site regulatory documents and approvals are in place prior to investigational product shipment Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews Analyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sites Maintains regular communication with study sites to ensure protocol/GCP compliance, assesses subject accrual rates, and responds to sponsor requests Conducts remote review of data entered on electronic Case Report Forms (eCRFs) as needed Works closely with field CRAs and data management to resolve queries on discrepant data Assists with efforts to recruit investigative sites to participate in clinical studies Complies with ICH GCP guidelines, FDA regulations, and company SOPs Participates in internal, client/sponsor, scientific, and other meetings as required Manages and resolves conflicting priorities to deliver on commitments Performs additional duties as assigned PREPARATION, KNOWLEDGE, SKILLS & ABILITIES BS/BA from an undergraduate program or equivalent experience At least 7 years of experience in clinical research Proven ability to be careful, thorough, and detail-oriented Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills Self-starter who thrives in a collaborative, yet less structured team environment Ability to problem-solve unstructured or ambiguous challenges Strong command of English, both written and verbal Excellent communication and interpersonal skills with customer service orientation Proficient with MS Office Suite, particularly Word and Excel Permanent authorization to work in the U.S. WORKING CONDITIONS/PHYSICAL DEMANDS Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs. Languages English Education Bachelor of Science (BS) Contract Type Regular

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.

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

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.

Join Immatics and shape the future of cancer immunotherapy; one patient at a time! Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics. Why Join Us? Innovative Environment: Help to pioneer advancements in cancer immunotherapy. Collaborative Culture: Be part of a diverse team dedicated to your professional growth. Global Impact: Contribute to therapies that make a lasting impact on patients globally. We are seeking a Clinical Research Associate II/Sr. to support our Clinical Operations. The Clinical Research Associate will be responsible for ensuring clinical trial site management and monitoring activities in compliance with GCP guidelines, national and local regulations or laws, and SOPs FLSA Classification: Salary, Exempt Schedule: Monday - Friday; 8:00 am - 5:00 pm; preferred Western region of USA Department: Clinical Operations Reports to: Associate Director, Clinical Operations Supervisory responsibilities: No Location: Fully Remote What You'll Do: As a Clinical Research Associate II/Sr., you will play a key role in supporting our Clinical operations: Support clinical trial site feasibility and site selection process Conduct all aspects of clinical monitoring for clinical trials including conduct of site qualification visits, site initiation visits, routine monitoring visits and close-out visits at clinical trial sites Support the maintenance of the Investigator Site Files and sponsor Trial Master Files Conduct all aspects of site management as prescribed in the clinical trial specific functional plans Prepare accurate and timely trip visit reports Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiates appropriate actions to achieve objectives Organize and make presentations at Investigator Meetings Participate in the development of Case Report Forms and clinical trial documents Act as primary contact for clinical trial supplies and other suppliers (vendors) Participate in regular clinical trial team meetings Secondary Functions: Mentor less experienced or new CRA colleagues Perform CTM tasks as appropriate and as delegated by the CTM Proactively contributes to continuous improvement of Clinical Operation specific processes, procedure and templates Required Experience and Education: Min. Bachelor's Degree, preferably in life science or nursing, or equivalent At least 4 years of on-site monitoring experience in the pharmaceutical/ biotechnology industry (incl. all monitoring visit types) In-depth knowledge of ICH-GCP, FDA and EMA and applicable local regulations and laws Understanding of basic medical oncology terminology and science preferable Exceptional attention to detail Advanced presentation and organizational skills Comprehensive understanding of priorities within own scope with limited interaction with the supervisor Proactively driving quality and efficiency to meet timelines and milestones in own scope Demonstrated computer skills, including Microsoft Office and clinical trial systems (i.e., eTMF, CTMS) Preferred Experience and Education: Proactively driving company standards, global harmonization and innovation in own scope Full reflection on complex process structures and connections Fostering innovation and development in own area of expertise Competencies Intermediate leadership skills and strong team player Positive attitude and willingness to learn and contribute to a team Proficient time management to work efficiently and economically Strong ability to identify, deeply analyze and communicate problems Advanced ability to develop and implement solutions within own area of responsibility Analytical reasoning and good project management skills Travel required: Willingness to travel up to 75%. Valid Driver's License preferable Physical demands: Communicating Verbally - expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly. Hearing - the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds. Keyboarding - entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others. Lifting - raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object - usually by holding it in the hands or arms but may occur on the shoulder. Near Visual Acuity - clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers). Pushing - Exerting force upon an object so that the object moves away from the object. Pulling - Exerting force upon an object so that the object moves toward the force. Sitting - remaining in a sitting position for at least 50% of the time. Standing/Walking - remain on one's feet in an upright position at a workstation. Stooping - occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles. Work authorization/security clearance requirements: Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment Affirmative Action/EEO statement: Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. What do we offer? At Immatics, we believe in investing in our team's health, safety and well-being. Here's what you can expect if you join Immatics Comprehensive Benefits: Competitive rates for Health, Dental, and Vision Insurance 4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment. Sick Time Off - 56 hours 12 Paid Holidays 100% Employer-Paid Life Insurance up to at 1x annual salary 100% Employer Paid Short- and Long-Term Disability Coverage 401(k) with Immediate Eligibility & company match… You are eligible for 401(k) plan participation as of your first paycheck. The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment. Partially paid Parental Leave for eligible employees. (3 weeks) Additional voluntary employee paid coverages including Accident, Hospital Indemnity, and Critical Illness Employee Paid Identity Theft Protection and Pet Insurance. Professional Growth: Opportunities to work with leading experts in the field of T-cell immunotherapy. Company provided learning and development opportunities Fast paced, high demand collaborative and dynamic environment.

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

Clinical Research Data Specialist II, Seidman Cancer Center (Hybrid) - (25000C70) Description What You Will DoIndependently coordinate and facilitate the clinical trial data for participants enrolled in clinical research studies conducted by principal investigator(s) at University Hospitals. Prepare and design data management study documentation. (20%) Assist and complete case report forms entry, review and abstraction required to conduct clinical research with the IRB, pharmaceutical sponsor, and other internal/external agencies or committees. (30%) Provide timely and professional ongoing management of clinical trial data by identifying and resolving errors and inconsistencies of data in accordance with study submission/completion guidelines for a variety of studies in different therapeutic areas and phases including IND or IDE held investigator initiated trials. (30%) Assure that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with SOPs, GCP guidelines, sponsor guidelines and current regulations. (20%) Provides mentorship and training on the clinical trial and data management process to staff members. Acts as a department liaison on interdepartmental committees. (10%) Additional ResponsibilitiesPerforms other duties as assigned. Complies with all policies and standards. For specific duties and responsibilities, refer to documentation provided by the department during orientation. Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace. Qualifications EducationBachelor's Degree (Required) and years of experience or research or data management certification (ie. SCDM, SoCRA or ACRP) can offset degree (Required) Work Experience3+ years of clinical research experience (Required) and Experience with computer operations and demonstrated computer skills in a variety of software environments (ie Excel, Access, Word, database applications). (Required) Knowledge, Skills, & Abilities Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively. (Required proficiency) Ability to work consistently and effectively as part of a high performance work team. (Required proficiency) Demonstrate problem solving skills and effective negotiation skills. (Required proficiency) Ability to understand and communicate data requirements to others. (Required proficiency) Medical terminology. (Required proficiency) Excellent verbal, written, interpersonal and written communication skills. (Required proficiency) Licenses and CertificationsCertification in Human Subjects Protection (CITI) (Required within 30 Days) Physical DemandsStanding Occasionally Walking Occasionally Sitting Constantly Lifting Rarely 20 lbs Carrying Rarely 20 lbs Pushing Rarely 20 lbs Pulling Rarely 20 lbs Climbing Rarely 20 lbs Balancing Rarely Stooping Rarely Kneeling Rarely Crouching Rarely Crawling Rarely Reaching Rarely Handling Occasionally Grasping Occasionally Feeling Rarely Talking Constantly Hearing Constantly Repetitive Motions Frequently Eye/Hand/Foot Coordination Frequently Travel Requirements10% Primary Location: United States-Ohio-ClevelandWork Locations: 11100 Euclid Avenue 11100 Euclid Avenue Cleveland 44106Job: ResearchOrganization: Clinical_Research_Center_UHCSchedule: Full-time Employee Status: Regular - ShiftDaysJob Type: StandardJob Level: ProfessionalTravel: NoRemote Work: HybridJob Posting: Dec 11, 2025, 1:23:04 PM

HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients. Location: Remote position, ideally candidates will live in a major metro area with an international airport in the Northeast, Southeast or West Coast. Travel Expectation: Travel (by automobile or air, day trips and overnight stays) up to 30% of the time. Position Summary: The Senior Clinical Research Associate will play a key role in proactively helping the conduct of pre-market and post-market global clinical studies to ensure compliance with all the regulatory requirements and company strategic initiatives. As a member of the Clinical Affairs team, this role will work with key stakeholders to execute clinical studies with minimal oversight. This role will be responsible for study site management, including site qualification, training, activation, and monitoring. Key Responsibilities: Works on assigned studies to ensure that human subject protection is maintained in accordance with Good Clinical Practice (GCP), SOPs, and applicable regulations Conducts on-site and remote site qualification, initiation, interim, and close-out monitoring visits Serve as primary point of contact for site questions relating to study enrollment and conduct; collaborate with appropriate study team members as needed Assists with the development and execution of clinical study documents including protocols, informed consents, case report forms, and study plans Communicates through verbal and written communication with site investigator and the project team on the overall site performance, trends, deficiencies, and concerns Ensures quality and completeness of central and site master files Oversees site investigational product requirements and device accountability Assists preparing sites for audits and in resolving action items Supports site audits as needed (on-site and remote) Supports the planning and coordination of Investigator Meetings Other duties as assigned Qualifications and Skills: 5+ years clinical research study monitoring for medical device or related experience BS degree in relevant area of study Knowledge of federal and local regulations and policies pertinent to research involving human subjects Knowledge of ICH, GCP, and Declaration of Helsinki Excellent communication, interpersonal and organizational skills Ability to collaborate in a team environment and work independently with minimal oversight Self-starter with the ability to manage multiple projects and effectively prioritize tasks in a dynamic, start-up environment Must be willing and able to travel (by automobile or air, day trips and overnight stays) up to 30% of the time HistoSonics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. #LI-Remote

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.

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

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