Clinical study manager work from home jobs - 267 jobs

Job Requisition: Clinical Research & Evidence Manager Company: Rho Nutrition Employment Type: Full-Time Reports To: VP of Science & Innovation Rho Nutrition is a fast-growing, science-driven CPG company redefining the supplement industry through liquid, liposomal delivery technology. Operating across Shopify DTC, Amazon, and national retail, Rho serves hundreds of thousands of customers and is scaling rapidly while maintaining strict standards around quality, transparency, and scientific rigor. Role Overview Rho Nutrition is seeking a Clinical Research & Evidence Manager to support the execution, organization, and application of our clinical research initiatives. This role will oversee external research partnerships and clinical studies while ensuring scientific evidence is clearly documented, maintained, and accessible to support internal decision-making across product development, education, and growth. The ideal candidate brings strong experience in clinical or applied research environments, is comfortable working with external research partners, and can translate complex study outputs into clear, structured insights for cross-functional teams. This role plays a key part in ensuring Rho's scientific foundation continues to scale alongside the business. Key Responsibilities Manage and coordinate clinical research initiatives, including observational studies, interventional trials, and PK or exploratory research Serve as the primary point of contact for external research partners, CROs, and study vendors Support IRB submissions, protocol updates, amendments, and study close-outs as needed Track study timelines, milestones, endpoints, and operational risks Organize and synthesize study outputs into clear internal scientific summaries and executive-level briefs Maintain structured evidence libraries organized by product, ingredient, and outcome Support internal teams by clarifying existing evidence and appropriate scientific context Partner cross-functionally with Product, Education, Marketing, and CX teams to ensure scientific information is accurately reflected across materials Identify emerging research needs as the product portfolio and business evolve Escalate ambiguous findings or limitations with clear context and recommendations Qualifications & Experience Advanced degree in a relevant scientific or clinical field (MS, MPH, PharmD, or equivalent) 3+ years of experience in clinical research, translational science, or applied research environments Hands-on experience working with clinical studies, research platforms, or CROs Strong ability to synthesize scientific data into clear, structured insights Experience operating in fast-paced, cross-functional environments Preferred: PhD or professional degree in a relevant discipline Experience in nutrition, dietary supplements, or consumer health products Familiarity with applied research in commercial or regulated settings What Success Looks Like in This Role Clinical research initiatives are well-organized, on track, and clearly documented Internal teams have clear visibility into available scientific evidence Study outputs are translated into usable insights for product, education, and planning Reduced ad hoc scientific questions routed to senior leadership Strong, productive relationships with external research partners Why Join Rho Nutrition Join a founder-led, science-driven brand at a critical growth stage Work remotely with a highly collaborative, high-caliber leadership team Play a meaningful role in shaping how scientific evidence supports a fast-scaling product portfolio Competitive compensation and long-term growth opportunities

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The Study Specialist will augment activities performed by existing study team members whether from client or client's preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. • This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development. • Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety. Organizational Relationships: • Oversight by client Clinical Operations Study Team Lead • Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur • Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead) Primary Duties: • Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff • Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes • Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites • Point of escalation for clinically identified site related issues • Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee • Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support) • Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality • Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file • Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client • Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training. • Complies with all departmental objectives and metrics related to study execution • Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge Secondary Duties • As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs • As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution • Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study • Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan Training and Education Preferred: • Bachelor's Degree in Life Science, RN preferred • Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring • Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinical trials highly desirable) • Demonstrated ability to problem solve and to prioritize site related activities • Demonstrates solid understanding of drug development and clinical practices • Understands and is able to comprehend study protocols • Has knowledge of FDA regulations • Possesses working knowledge of GCPs and other regulations governing clinical research • Demonstrates technical expertise in computer skills • Demonstrates diligent and self-motivated approach to working in an independent environment • Demonstrates effective oral and written communication skills • Travel anticipated at 25% but could up to 50% at times. Qualifications BS/MS Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960

Paradigm is rebuilding the clinical research ecosystem by enabling equitable access to trials for all patients. Our platform enhances trial efficiency and reduces the barriers to participation for healthcare providers. Incubated by ARCH Venture Partners and backed by leading healthcare and life sciences investors, Paradigm's seamless infrastructure implemented at healthcare provider organizations, will bring potentially life-saving therapies to patients faster. Our team hails from a broad range of disciplines and is committed to the company's mission to create equitable access to clinical trials for any patient, anywhere. Join us, and bring your expertise, passion, creativity, and drive as we work together to realize this mission. The Opportunity As a Clinical Trials Solutions Lead, you will serve as a senior-level, strategic leader responsible for designing and delivering tailored, high-impact solutions that meet the complex needs of Paradigm's global partners. Working across business development, operations, clinical, and delivery, this role combines strategic thinking with operational expertise to ensure clinical trial solutions are both innovative and feasible. You will own end-to-end proposal creation for our newly acquired Phase IV observational trials offering, coordinate clinical experts and data sources, and build the foundational playbook for scalable, client-ready submissions. This position is ideal for someone who thrives at the intersection of technology, clinical operations, and client engagement-someone passionate about reshaping how clinical research reaches patients everywhere. Key Responsibilities Act as the central point of contact for the development of Phase IV proposal materials, including customer-facing slides, data-driven study enrollment projections, budget & pricing calculators, and operational/study design documents Coordinate and secure timely input from clinicians, medical experts, and cross-functional internal teams to meet proposal deadlines Liaise with Commercial Finance on the development of budget and pricing calculators Partner with business development leaders to translate client requirements into scalable, technically feasible delivery models - including understanding and breaking down customer use cases, designing study concepts, and aligning on execution and operational approaches to ensure a smooth handoff to delivery teams Present proposal content and study design recommendations in stakeholder- and client-facing reviews Identify risks or gaps in proposals early and drive pragmatic solutions under tight timelines Manage proposal timelines and deliverables as the proposal owner, ensuring quality, accuracy, and on-time delivery Support project management teams with best practices in delivery, governance, and operational excellence. Establish and document repeatable proposal workflows, templates, and best practices to reduce future cycle time and variation. Qualifications Bachelor's degree in life sciences, engineering, or related field (advanced degree preferred). 10+ years of experience in clinical research, life sciences consulting, or healthcare technology, ideally in solution architecture, project management or project delivery. Deep understanding of clinical trial operations, regulatory environments, and site or sponsor ecosystems. Proven ability to lead solution design for complex, multi-stakeholder projects. Exceptional communication, presentation, organizational, and relationship-management skills. Demonstrated success driving quality-focused, client-centric outcomes in a dynamic environment. Comfort executing in ambiguous, rapidly evolving businesses with a demonstrated bias for action Expert level Google Sheets capabilities Why Join Paradigm Mission-driven culture dedicated to equitable access to clinical trials for any patient, anywhere. Collaborative, multidisciplinary team driven by innovation and continuous improvement. Opportunity to make a tangible impact on the future of clinical research through cutting-edge technology and strategic partnerships. The base compensation range is $160,000- $200,000 USD per year. Actual salaries will vary based on candidates' qualifications, skills, and location. What You'll Receive: Paradigm Health offers a comprehensive Total Rewards package to support your well-being and success, including: Competitive health, dental, and vision insurance Mental health support for you and your family through Spring Health Equity package Unlimited paid time off (PTO) 16 weeks of paid parental leave Flexible work options - remote and hybrid arrangements Company-paid life insurance Company-paid short-term and long-term disability coverage One Medical membership 401(k) plan with company match At Paradigm, we are committed to providing equal employment opportunities to all qualified individuals. We encourage and welcome candidates from all backgrounds and perspectives to apply for our open positions. We are interested in all qualified individuals and ensure that all employment decisions are based on job-related factors such as skills, experience, and qualifications.

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 Clinical Trial Manger (CTM) to join our growing Clinical Operations team! In this newly created role, you will be accountable for the operational management and execution of global clinical trial programs (Phases I-III). You will be responsible for ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. A key focus is partnership with CROs and other 3rd party vendors to oversee and ensure study milestones and deliverables are achieved according to agreed quality standards and timelines, and that the quality of data is suitable for regulatory submission/inspections. You will have visibility and regular interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. Key Responsibilities Oversee study scope, quality, timelines, and budget with the internal functional leads, CRO, and vendors to ensure overall project objectives are met Initiate and build strong relationships with key opinion leaders and clinical site staff Partner with the CRO to ensure robust patient enrolment strategies are developed and effectively implemented, on time and within budget for assigned regions Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and effectively implemented to ensure delivery of high-quality data Proactively identify and manage study related risks Develop and manage clinical trial documents, including but not limited to protocols, Case Report Forms (CRFs), and consents Review and manage study related plans and processes including Investigator agreements (CTA), site budget review, CRFs, CRF guidelines, Statistical Analysis Plans, Pharmacokinetic Analysis Plans, Monitoring plan, Data Management Plan, and Safety Monitoring Plan Collaborate with Regulatory/CRO team members to assist with completion/review of regulatory submissions Review CRO and vendor contracts/work orders and specifications to align with study objectives Review specifications for systems build and participate in User Acceptance Testing (UAT) (eg, IRT, eCOA, EDC) Participate in data cleaning and manage database lock activities with cross functional team Oversee review and approve essential document packages to enable timely site activations Direct investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Participate in TMF review and ensure quality and completeness throughout end of the study Ensure the study is always “inspection ready” Oversee and coach the functional activities of Clinical Trial Associates allocated to the project Ideal Candidate Bachelor's degree in life science or equivalent Minimum of 5 years of clinical trial management experience in conducting international clinical trials in a Sponsor Pharma/Biotech organization. Biotech experience strongly preferred. Prior phase II and III experience required A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process Proven proficiency in overseeing complex studies being managed in house and by a CRO Demonstrated ability to lead teams and work in a fast-paced, cross functional environment, and able to think critically and creatively Experience selecting and managing clinical vendors to support study activities Enjoys building relationships with KOLs and site personnel Demonstrated ability to build and deliver on patient enrolment strategies Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives Demonstrated ability to review and comprehend complex scientific concepts and clinical data Strong planning, time management, and coordination skills Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Excellent written and oral communication skills Position requires up to 35%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 $145,000- $160,000 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.

About Us… Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian's programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian's lead program is currently in preclinical development for the treatment of patients with metastatic melanoma and other solid tumors. We're proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our brand-new facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options. Our Opportunity… We're seeking a highly organized, hands-on, collaborative, and experienced Clinical Trial Manager to oversee our early phase cell therapy oncology clinical trials (targeting metastatic melanoma and non-small cell lung cancer). You will facilitate collaboration with internal and external study teams to ensure patient recruitment, timelines, quality standards, Good Clinical Practices and applicable regulations are being met throughout all stages of the study. As part of our Clinical team, you'll play a vital role in achieving Obsidian's vision by translating innovative science into medical breakthroughs for patients, starting with our lead program OBX-115 engineered to make TILs more effective for more patients. We are seeking an individual who takes ownership and brings knowledge and experience to oversee our clinical studies, anticipate and mitigate risks, exercise good judgement, and help us build an excellent clinical operations practice. This role will begin as an individual contributor, with potential to lead a team as our studies progress. This is a unique opportunity to contribute to advancing a novel cell therapy that has the potential to become a meaningful option for patients with advanced or metastatic melanoma and other solid tumors. Supported by blue chip investors, field-leading advisors, best-in-class partners, and an experienced team, you'll be part of a dynamic, innovative, passionate, and collaborative team. You Will... Support all clinical aspects of clinical trial operations from site selection and qualification, through study initiation to close out ensuring study deliverables are met on time and all relevant metrics are tracked and reported. Contribute to the development of study execution plans, partner with internal and external teams (Regulatory Affairs, Program Management, CMC, CRO, investigators/site staff, specialty labs, etc.), identify and mitigate risk throughout the study lifecycle. Assist in development of study budget, review and approve clinical invoices, and oversee expenses to ensure all fall within approved budget. Oversee study start up and site initiation activities and ensure clinical research staff including CRO, CRAs, sites and other contract personnel receive study-specific training and leadership. Contribute to writing clinical protocols, study related documentation (ICF template, CRFs, CRF Completion Guidelines Monitoring Plan, Laboratory Manual, TMF plan, Pharmacy Manual, etc.) and regulatory documents such as INDs. Prepare and review site study documents (e.g. site-specific informed consent, study tools/worksheets, investigator contracts, and site payments). Ensure the Trial Master File (TMF) documentation is complete and up to date. Oversee laboratory sample management and ensure clinical supplies are available for sites. Participate in quality assurance activities (review of protocol deviations, site specific CGP issues, review of monitoring reports, etc.) and ensure audit-ready condition of clinical trial documentation including central clinical files/Trial Master Files. Oversee clinical monitoring activities ensuring compliance with ICH/GCP and applicable regulations. Assist in developing and managing an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met. Prepare and present project briefings as required. Plan and facilitate study-specific meetings with CRO or other vendors (e.g., Study Management Meetings, investigator meetings, etc.). Participate in selection and management of external vendors, develop vendor specifications, and review vendor reports, budgets, and metrics. You Bring... Core Qualifications BS/BA/RN Degree with 8+ years of experience in a life science or a health-related field is preferred. Minimum of 5+ years working on phase I-IV clinical studies, ideally at a sponsor, CRO or clinical study site in management of oncology, rare disease, or cell/gene therapy trials Strong understanding of regulatory (e.g., ICH-GCP, FDA and EU regulations) and Compliance requirements Biotech/biopharma sponsor experience, including oversight of CROs in multi-site studies. Strong understanding of clinical study data review and data management processes, including Data Monitoring, protocol deviations, and overall data integrity of studies. Initiative to recognize gaps and opportunities for improvement and develop solutions. An ability to manage multiple responsibilities in parallel in a dynamic and fast paced environment with high standards. Exceptional attention to detail, organization, and record-keeping. Excellent oral and written communication skills Analytical thinking; proactive and intuitive about clinical trial issues/risks Exceptional risk mitigation and problem-solving skills Proficient in MS Office Suite Ability to travel up to 20% Preference to West Coast or Boston Area, if in either location occasional in office time is expected. Bonus Qualifications experience working from sponsor side and overseeing CRO and other external vendor management Familiarity with GxP inspection preparation Obsidian is committed to equitable and transparent pay practices. The anticipated base salary range for this role is below. The actual base salary offered will be determined based on a combination of factors, including applicable qualifications, level of education, the depth of experience, unique skills, geographic location, internal equity, and/or business needs. The actual base salary offered will be in accordance with federal, state, and/or local wage requirements for the role's location. Our competitive compensation package includes an annual incentive bonus as a percentage of actual base salary and long-term incentives in the form of employee stock options, both of which are commensurate with the role's level. We also offer a generous benefits package which includes comprehensive medical, dental, and vision coverage; company contributions to health savings and retirement accounts; ample paid time off; access to wellness programs; and rich career growth opportunities. Anticipated Base Salary Range$114,500-$140,000 USD Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Position Summary: The Clinical Trial Manager (CTM) is responsible for the end-to-end operational oversight of clinical trials, from study planning through close-out and reporting. This role ensures trials are executed ethically, on time, within budget, and in full compliance with applicable regulatory requirements and Good Clinical Practice (GCP), while maintaining the highest standards of patient safety and data integrity. Responsibilities: Provide operational leadership for one or more clinical studies or programs, overseeing execution from initial study synopsis through final deliverables, including study start-up, enrollment, conduct, database lock, statistical outputs (TLFs), and Clinical Study Report (CSR) Lead study start-up activities in collaboration with CROs and investigational sites, including oversight of clinical document development and site activation activities Manage day-to-day study execution, ensuring adherence to timelines, milestones, budgets and quality standards Contribute to and review study plans, timelines, and operational deliverables; proactively identify risks and implement mitigation strategies to ensure successful study outcomes Prepare, review and/approve study-related documents including but not limited to Informed Consent Forms, CRFs, Monitoring Plans, Laboratory Manuals, Patient Diaries, Clinical Site Procedures Manual and CRF Completion Guidelines) Implement risk management and mitigation strategies, prioritizing tasks and issues to ensure successful program/study objectives Participate in and support user acceptance testing (UAT) for clinical systems, (e.g., EDC IRT), including contribution to system requirements and validation activities Oversee vendor performance and relationships including CROs, central laboratories, and contribute to or lead the systems set-up/management, EDC/IRT, and specialty services (ePRO, ECG, imaging etc.) Ensure compliance with GCP, applicable regulations, SOPs, and study-specific procedures throughout the trial lifecycle Track, analyze and communicate study progress, risks and key metrics to the Study Lead and senior management, including development and maintenance dashboards and trackers Represent Clinical Operations professionally, fostering productive relationships with investigators, CRO partners, vendors and internal cross functional teams Qualifications: Bachelor's degree in Life Sciences, Nursing, or a related field with 5+ years of experience in clinical trial management or related clinical research roles; equivalent experience may be considered Master's degree and clinical research certification (e.g., CCRA, CCRP) strongly preferred Demonstrated knowledge of current clinical trial processes, GCP, ICH guidelines and regulatory requirements Strong project management skills, including managing of timelines, budgets, and cross-functional resources Excellent written and verbal communication with the ability to lead cross-functional teams and external partners. Proven problem-solving skills and tools, and ability to manage complex operational issues in a fast paced environment Experience with clinical trial systems and tools including EDC, IRT and Veeva Vault platforms,) Ability to travel occasionally to clinical sites, investigator meetings, and professional conferences as required Remote work considered; preference for candidates able to attend the office weekly (Fremont or Boston) The anticipated annualized base pay range for this full-time position is $136,000-$160,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.

At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. The Role The Clinical Trials Quality Manager is responsible for monitoring the quality and consistency of data and clinical operations at network clinical research sites throughout specific locations within the United States and Canada. This role will ensure that quality is built into all site processes and will partner with Headlands Operations employees to verify quality outcomes. This role will help the company succeed by reinforcing adherence to best-in-class processes, Good Clinical Practice, and federal and local regulations related to clinical research. Headlands employees are passionate about advancing healthcare. In this role, we hope you are just as passionate about supporting a patient experience that is safe, reliable, and compliant. Excellent communication and deductive reasoning skills are essential. If you also have experience monitoring clinical research sites, we would like to connect with you! Responsibilities: Create and maintain new Standard Operating Procedures (SOPs), Work Instructions, and other guidance at the network and site levels in compliance with ICH-GCP and federal, state, and local regulations (United States and Canada) as applicable Review and edit existing SOPs, work instructions, and other guidance at the network and site levels for compliance with applicable regulations (local to both the United States and Canada) and conformity to network SOPs Support the development and delivery of network and site-level training events, as requested, in various formats Conduct consistent internal study review activities to ensure compliance with ICH-GCP and applicable regulations (local to both the United States and Canada) Prepare and deliver an official report detailing internal study review activities performed, categorize any findings based on level of risk, and propose actions to correct any issues or noncompliance Work with the aligned operations team to remediate any issues or noncompliance identified at the site and implement preventive action as appropriate Participate in other requested quality investigations Assist site operations team to develop, implement, and track Corrective and Preventive Action plans (CAPAs) within the assigned region Routinely assess and report to operations on the risks impacting each site in the assigned region Conduct and report on the quality reviews of external sites as part of the Mergers & Acquisitions (M&A) due diligence process Participate in the integration of newly acquired sites into the network according to the integration playbook Share best practices to maintain a constant state of site inspection readiness Attend external audits and provide updates to internal leadership Track and assist in the required training of Headlands employees in the assigned region Support the development and delivery of training materials for site employees (CRIO, applicable network systems, etc.) Help site directors assess employee performance to quality standards, particularly in the 90-day probationary period after hire Participate in continuing education opportunities to stay up to date on relevant quality initiatives, regulatory guidance, and industry best practices Travel required up to 30%, domestically and/or internationally Requirements: Bachelor's degree or equivalent required Will consider Associates Degree with 5+ years of equivalent experience Certification by a professional clinical research organization preferred 5+ years of experience creating, reviewing, and delivering SOPs, work instructions, and training to ensure consistent quality across sites. Experience conducting internal and external audits, monitoring inspections, and preparing formal quality reports. Demonstrated ability to develop, implement, and track corrective and preventive action plans (CAPAs). Experience creating, reviewing, and delivering SOPs, work instructions, and training to ensure consistent quality across sites. Ability to identify quality risks, assess impact, and recommend corrective/preventive measures. Familiarity with decentralized or networked clinical trial operations, including multi-site management in US and Canada. Excellent knowledge of current federal and local regulations on clinical research and GCP Demonstrates skills highly adaptable from another cGXP work environments Extreme attention to detail Ability to communicate and work effectively with a diverse team of professionals Strong communication and organizational skills Comfortable taking direction from supervisor or working with autonomy. Proficient computer skills and use of MS Office Ability to build rapport with employees and external clients Comfortable traveling up to 30% of the time, domestically or internationally (Canada)

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

COMPANY BACKGROUND Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis). We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others. Job Summary Reporting to the VP Clinical Development, the Principal Clinical Scientist will contribute to the execution of the Phase 3 clinical development programme for EFX. Key responsibilities include, but are not limited to clinical protocol development, medical monitoring, data analysis and reporting of results for regulatory submissions or scientific presentations and publications. This position demands strong collaborative and communication skills, including the ability to engage with a diverse range of internal and external stakeholders. Job Responsibilities Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution Support medical monitoring activities for ongoing clinical trials. Support/manage preparation of materials for trial-related clinical committees such as Data Monitoring Committees, Adjucation Committees, etc. Contribute to planning, authoring, and critical review of documents submitted to regulatory authorities and ethics committee/IRBs as required (e.g., Protocols, CSRs, IB, clinical briefing documents). Contribute to the strategic planning, authoring, and critical review of scientific data disclosures (e.g., slide presentations, posters and publications). Co-ordinate aggregate report preparation (e.g., DSURs, PSUSARs, ASR), and safety management plans (SMPs) in collaboration with external vendors Contribute to engagement with external stakeholders such as vendors, thought leaders or other groups as needed including being the primary liaison with assigned individuals or groups. Function as an independent member of the team and represent clinical research at internal cross-functional or external meetings. Other duties related to clinical development of EFX as assigned. Qualifications PhD, PharmD or other qualification with relevant professional experience, (e.g. RN, NP, PA) At least 5+ years of relevant experience in clinical development in the biopharmaceutical industry Direct experience of Phase 3 clinical trial execution and medical monitoring support Experience with preparation of documentation for BLA/NDA/MAA submissions desirable Knowledge of the regulatory path across the various health authorities (FDA, EMA etc) desirable Experience in in Hepatology, Gastrointestinal, Endocrinology or related field, preferred. Technical Requirements and Skills: Familiarity with GCPs, ICH guidelines and FDA/ EMA/CHMP regulations and ability to apply relevant principles, practices and standard to conduct GCP-compliant trials Demonstrated ability to author or oversee regulatory documents (e.g protocols, CSRs, briefing packages). Strong interpersonal and communication skills; proactive approach. Expertise in navigating scientific literature and ability to critically evaluate, interpret and synthesise scientific data, Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, flexibility, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures. Able to work both independently and in a team environment, including with external vendors. Detail-oriented, with good organizational, prioritization, and time management proficiencies, and able to work on multiple projects simultaneously. Highly proficient in MS Office Suite (Word, Excel and Power Point). The base compensation range for this position is $148,290 to $259,510. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Akero Therapeutics, a Novo Nordisk company, offers long-term incentive compensation depending on the position's level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. The job posting is anticipated to close on February 4th. The Company may however extend this time-period, in which case the posting will remain available on our careers website at ************************************** EEO Statement: Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn's lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). Avalyn has initiated a Phase 2 study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn. Position Overview: The Clinical Trial Assistant will provide general administrative and project support for clinical research studies. He/she will provide day-to-day operational support to the Clinical Operations and Study Management teams across Avalyn's clinical trials spanning PH 1-2b and beyond. This role will support study start-up, ongoing study conduct, and close-out activities in close collaboration with CRO partners, external vendors, and internal cross-functional teams. The Clinical Trial Assistant will help coordinate global clinical trial activities by tracking key study milestones, deliverables, and timelines across investigational sites, and will assist in the preparation and organization of study materials for Investigator Meetings, Site Initiation Visits (SIVs), and other study-related meetings and communications. Responsibilities: · Support TMF related activities (sending / tracking Avalyn vendor documents to CRO TMF, TMF QC and reconciliation (through life of the trial and final reconciliation) Including conducting TMF audits based on the timing outlined in the applicable study plans communicating issues identified to the CRO and tracking resolution of the identified issues. · Create and maintain a SharePoint study file organization structure; build a file folder format consistent with TMF reference model to use consistently across all trials. · Assist with study start-up, maintenance, and close-out activities in collaboration with CROs, vendors, and internal cross-functional teams. · Responsible for coordination of meetings and generate meeting minutes · Will assist in building Smartsheet or similar workspaces to house various study specific trackers allowing for a central location · Responsible for supporting Data Review, identifying gaps/missing data, outliers, etc) to ensure accuracy of data. Track and report status of issues to resolution, escalating when appropriate. · Support GCP compliance and inspection readiness activities by ensuring study documentation is complete, accurate, and well organized. · Assist with internal audits, inspection preparation activities, and responses to audit findings as needed. Required Qualifications: · Minimum of Bachelor's degree in Life Sciences, Health Sciences, Nursing, Public Health, or a related field (or equivalent relevant experience) · 2+ years of experience in Clinical Operations, Clinical Research, or a related clinical trial support role (industry or CRO) · Working knowledge of clinical trial documentation and Trial Master File (TMF) requirements including the CDISC TMF reference model · Experience supporting TMF activities, including document collection, filing, tracking, and basic QC · Familiarity with electronic TMF (eTMF) systems and document management best practices · Experience with TMF related activities (sending / tracking Avalyn vendor documents to CRO TMF, TMF QC (set a frequency through life of the trial and final recon) · Ability to build, maintain, and update study trackers (e.g., Excel, Smartsheet, or similar tools) · Strong attention to detail with the ability to identify missing, inconsistent, or incomplete information · Excellent organizational, time management, and prioritization skills · Strong written and verbal communication skills, including the ability to document meeting minutes clearly and concisely · Ability to work collaboratively, as well as independently. with cross-functional teams, CROs, and external vendors · Must be familiar with ICH GCP and appropriate regulations · Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) Proposed pay range$90,000-$125,000 USD

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. 1 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

SummaryAs the Clinical Scientist - Interventional, you will be responsible for 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 DescriptionEssential Responsibilities: 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 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 research and development teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns Grow technology leadership mindshare through joint scientific presentations and publications Lead and represent the global modality technical, scientific and product expertise in the US and Canada 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 Qualifications/Requirements: PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field Preferred 1+ year(s) of experience in Interventional healthcare industry or clinical research Experience with imaging modalities and dose analysis Knowledge of Interventional procedures, anatomies, clinical practice Knowledge of Interventional products including IGS product line and Advantage Windows applications 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 ( 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. 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. 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 $100,000.00-$150,000.00 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. 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: Yes

ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities. Position Summary Responsible for clinical trials administration to ensure the most effective and efficient conduct of clinical research studies. Essential Functions Support the Clinical Operations teams in the completion of all required tasks to meet trial, departmental and project goals. Maintain, share and champion a thorough knowledge ICH GCP, appropriate regulations, relevant SOPs and internal tracking systems. Collaborate with Clinical Trials Manager (CTM) and Clinical Research Associates (CRAs) to resolve clinical trial documentation issues. Establish, organize and maintain clinical study documentation (e.g. Trial Master File, study level and site level documents, etc.) including preparation for internal/external audits, final reconciliation and archival. Review clinical trial documents to determine compliance with Good Documentation Practices (GDocP), file and track study documents. Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution. Audit Investigator/Site invoices for accuracy, and reconcile invoices against the case report forms (CRFs) and budget for payment submission. Gather central IRB report information, submit the report to the central IRB portal and track the IRB submissions from beginning through approval. Facilitate the collection and review of required study documents during site start-up Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.) Route study documents to the appropriate personnel for validated digital signatures Submit purchase requisitions to Enterprise Resource Planning (ERP) System for Clinical Operations functional groups as needed. Request invoice approval from internal supplier designee. Participate in clinical operations safety reporting activities; distribute, file and track safety reports and IRB submissions. Facilitate clinical operations team meeting coordination, agenda preparation and meeting minutes preparation Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor's degree with 0-2 years of clinical research experience required; or High school diploma with 5+ years of clinical research experience required Knowledge, Skills, & Abilities Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe Excellent written/oral communication skills as well as strong organizational and multi-tasking skills Maintain corporate confidentiality at all times. Strong oral and written communication skills Detail oriented, with solid organization and time management skills Working knowledge of good documentation practices (GDP) Working Environment / Physical Environment This position works on site in El Segundo, CA or remotely depending on the candidate's geographic location Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. National Market (all markets unless identified as Premium) $70,000 (entry-level qualifications) to $77,000 (highly experienced) annually Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $73,800 (entry-level qualifications) to $81,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate II/ Sr. Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. CRA's must have Oncology experience, GVHD would be nice but not required. They should be willing to do dermatology if requested. What you will be doing * Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. * Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. * Collaborating with investigators and site staff to facilitate smooth study conduct. * Performing data review and resolution of queries to maintain high-quality clinical data. * Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile * Bachelor's degree in a scientific or healthcare-related field. * Minimum of 2 years of experience as a Clinical Research Associate. * In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. * Strong organizational and communication skills, with attention to detail. * Ability to work independently and collaboratively in a fast-paced environment. * Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Salary range: $110,520.00-$138,150.00 Bonus, Com, Stock, Benefits & Disclaimer verbiage: Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance. Are you a current ICON Employee? Please click here to apply

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 * Contracts Manager * Associate Instock Manager - Associate Instock Manager I * Director of Clinical Solutions * Development Associate

Clinical Research Monitor 1, Research Administration, FT, 08:30A-5P-156133 Baptist Health is the region's largest not-for-profit healthcare organization, with 12 hospitals, over 28,000 employees, 4,500 physicians and 200 outpatient centers, urgent care facilities and physician practices across Miami-Dade, Monroe, Broward and Palm Beach counties. With internationally renowned centers of excellence in cancer, cardiovascular care, orthopedics and sports medicine, and neurosciences, Baptist Health is supported by philanthropy and driven by its faith-based mission of medical excellence. For 25 years, we've been named one of Fortune's 100 Best Companies to Work For, and in the 2024-2025 U.S. News & World Report Best Hospital Rankings, Baptist Health was the most awarded healthcare system in South Florida, earning 45 high-performing honors. What truly sets us apart is our people. At Baptist Health, we create personal connections with our colleagues that go beyond the workplace, and we form meaningful relationships with patients and their families that extend beyond delivering care. Many of us have walked in our patients' shoes ourselves and that shared experience fuels out commitment to compassion and quality. Our culture is rooted in purpose, and every team member plays a part in making a positive impact - because when it comes to caring for people, we're all in.Description The Clinical Research Monitor will be responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance. Responsible for all aspects of monitoring management as prescribed in the monitoring plan. (S)he is responsible to: 1) Perform site visits (on-site or remotely), including Pre-Study, Initiation, Routine and Closeout visits, 2) Ensure study staff have received the proper materials and instructions to safely enter patients into the study, 3) Review completion of proper informed consent procedures according to the applicable regulatory requirements, 4) Ensure the integrity of the data, 5) Interpret data to identify protocol deviations and risks to subject safety/data integrity, 6) Generate queries and manage resolutions with site personnel, 7) Perform investigational product accountability as per the protocol and Study Monitoring Plan, 8) Evaluate execution of study protocol at the site level, 9) Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance, 10) Document activities via confirmation letters, follow-up letters and other required study documents as per SOP and Study Monitoring Plan. Estimated salary range for this position is $65835.36 - $85585.97 / year depending on experience.Qualifications Degrees:Bachelors Degree is required.Additional Qualifications:Bachelor‘s degree required.Master‘s degree and CCRA (Certified Clinical Research Associate) preferred.Ability to problem solve and multi-task, excellent computer skills.Proficient in Windows, MS Word, Excel.Possesses knowledge of Good Clinical Practice (GCP), FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions.Knowledge of basic human anatomy, physiology, medical terminology.Prior experience in Oncology preferred.Ability to communicate effectively and with a high level of professionalism across various stakeholders.Minimum Required Experience: 5 YearsJob Non-Clinical and AdministrativePrimary Location RemoteOrganization Miami Cancer Institute at Baptist HealthSchedule Full-time Job Posting Jan 26, 2026, 5:00:00 AMUnposting Date OngoingEOE, including disability/vets

We are hiring PhD candidates at Medpace! The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with a Life Science background who want to explore the research field, travel the US, and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you! Positions are office based in our Irving, TX. MEDPACE CRA TRAINING PROGRAM (PACE) No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE. Training Program, you will join other Professionals Achieving CRA Excellence: PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA. PACE will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums. To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process. WHY BECOME A CRA This role takes you on a journey through travel and excitement which will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. The CRA position provides many other distinctive advantages including: * Dynamic working environment, with varying responsibilities day-to-day * Expansive experience in multiple therapeutic areas * Work within a team of therapeutic and regulatory experts * Defined CRA promotion and growth ladder with potential for mentoring and management advancements * Competitive pay and many additional perks unmatched by other CROs (SEE BELOW). WE OFFER THE FOLLOWING Competitive travel bonus; Equity/Stock Option program; Training completion and retention bonus; Annual merit increases; 401K matching; The opportunity to work from home; Flexible work hours across days within a week; Retain airline reward miles and hotel reward points; Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere; In-house travel agents, reimbursement for airline club, TSA pre-check; Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more; CRA training program (PACE); Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts; In-house administrative support for all levels of CRAs; and Opportunities to work with international team of CRAs. Responsibilities * Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; * Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; * Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; * Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; * Verification that the investigator is enrolling only eligible subjects; * Regulatory document review; * Medical device and/or investigational product/drug accountability and inventory; * Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; * Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and * Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Qualifications * Must have a minimum of a Bachelor's degree in a health or science related field; PhD preferred * Ability to travel 60-70% to locations nationwide is required, or less if remote/virtual visits required; * Must maintain a valid driver's license and the ability to drive to monitoring sites; * Minimum 1 year healthcare-related work experience preferred; * Proficient knowledge of Microsoft Office; * Strong communication and presentation skills; and * Must be detail-oriented and efficient in time management. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Dallas Perks * Dallas Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with nonprofit organizations * Structured career paths with opportunities for professional growth * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Free on-site parking * Outdoor seating and workspace Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. The GI Therapeutic Area within Lilly Immunology Development is focused on developing new therapies for patients with gastrointestinal diseases. The GI immunology development team is seeking a motivated clinical research scientist that is passionate about drug development within gastroenterology. The candidate must have extensive drug development experience in mid-to-late phase trials. They will engage in various trial related activities including but not limited to the development, conduct and reporting of global clinical trials in support of registration and commercialization of new therapies; the reporting of adverse events; the drafting and review process for protocols, study reports, publications; engagement with global regulatory authorities and other governmental agencies; outreach medical activities including thought leaders engagement. Key Objectives/Deliverables The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned. Clinical Planning: product lifecycle plan, clinical strategies, development plans and study protocol design. Provide subject matter expertise and keep updated with the pre-clinical and clinical data relevant to the molecule Clinical Trial Execution and Support: Plans, collaborates on and reviews scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions. Supports the monitoring of patient safety during study and engages in the global product safety reviews. Cross function collaboration with clinical trial teams in the design, conduct and reporting of mid to late phase clinical trials. Conduct study start-up meetings, investigator meetings and other activities to provide the appropriate training and information to investigators and site personnel. Scientific Data Dissemination/Exchange: engage in reporting of clinical trial data in Clinical Trial Registry activities. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals. Establish and maintain collaborations and relationships thought leaders. Support clinical trial data analysis and publications. Regulatory Support Activities: Provide medical expertise to regulatory scientists and support regulatory strategy. Scientific and Technical Expertise and continued development: Acts as scientific consultant and protocol expert for clinical study team members and others in medical. Minimum Requirements PharmD, PhD in health/medical/scientific (for example, in Pharmacology, physiology, microbiology) 3+ years of clinical development experience, including mid-to-late-stage development Additional Skills/Preferences Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills Previous GI drug development experience Pediatric drug development experience Oral/written communication/listening skills are essential Strong relationship-building and interaction skills with peers and management Preferred location is Indianapolis, though remote arrangements may be considered Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $338,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly