Source Job

• Lead TMF activities for clinical trials across start-up, maintenance, close-out, and archive phases.
• Oversee eTMF health, quality issue workflows, and compliance with regulatory standards.
• Support TMF document processing, audits, and continuous improvement initiatives.

Akero Therapeutics is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases such as MASH. They are part of Novo Nordisk and foster a collaborative culture with diverse skill sets.

• Manage TMF operations activities for multiple complex studies or sponsor portfolios.
• Oversee Trial Master File quality control including planning, tracking, and reporting.
• Support regulatory inspections and sponsor audits while collaborating with cross-functional teams.

This is a global clinical research environment focused on ensuring accuracy, compliance, and quality of essential trial documentation. The company operates with a collaborative international team and values inclusion, professional growth, and purpose-driven healthcare work.

• Lead end-to-end TMF strategy, including transition from outsourced to in-house operations.
• Ensure TMF health and inspection readiness through governance, quality control, and metrics.
• Serve as TMF subject matter expert and partner cross-functionally for document flow and compliance.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. The company is guided by core values of collaboration, innovation, and ownership, and is committed to transforming treatment for autoimmune disease.

• Lead and mentor a high-performing team of Clinical Research Associates, ensuring operational excellence and efficient resource utilization.
• Manage hiring, onboarding, performance management, and professional development activities for CRA staff.
• Collaborate with Project Managers and cross-functional teams to support successful delivery of clinical trials.

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a balance between stability and innovation. They focus on delivering quality and on-time services across various therapeutic indications.

• Provides study-level oversight and leadership for global clinical trials from inception through closure, managing vendors, recruitment, and cross-functional teams.
• Develops and manages study materials including protocols, regulatory submissions, and budgets while ensuring compliance with quality standards and inspection readiness.
• Contributes to system management like EDC, IRT, and eTMF, and supports process improvement initiatives or serves as a mentor.

AbbVie discovers and delivers innovative medicines and solutions to address serious health issues in immunology, oncology, neuroscience, and aesthetics. As a global biopharmaceutical company with a robust pipeline, they emphasize integrity and innovation, serving patients worldwide with a dedicated team.

• Manage clinical operations including study management, biospecimen acquisition, and regulatory compliance.
• Lead and mentor a team of CRAs and clinical trial logistics personnel.
• Develop and implement processes and tools for high-quality trial management.

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. They are dedicated to delivering better solutions and have an innovative culture focused on collaboration and cutting edge solutions.

• Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development/production with a focus on quality and compliance.
• Provide oversight of CROs, vendors, and internal teams, recruiting and leading CDM staff to meet clinical trial timelines and budgets.
• Partner cross-functionally on data management issues, identify risks, and propose solutions to ensure inspection-ready, high-quality data.

Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders. Headquartered in New York and traded on Nasdaq (DFTX), the company is advancing a new generation of therapeutics with a focus on turning evidence into impact.

• Develop, mentor, coach and manage CTMs to progress their skillset per quality standards.
• Collaborate with management to enhance CTM expectations and procedures for quality and efficiency.
• Ensure CTMs have proper resources and training to deliver high-quality study conduct.

Precision for Medicine is a clinical research organization (CRO) that provides clinical trial management services. The company employs a large team of clinical research professionals and emphasizes quality and collaboration.

• Create and execute clinical operational strategic plans aligned with product strategy and resource allocation.
• Build, develop, and train internal staff and external vendors to enhance efficiency and engagement.
• Oversee relationships with Contract Research Organizations, vendors, and investigative sites to ensure compliance with FDA and ICH GCP guidelines.

Lycia Therapeutics is a biotechnology company using its proprietary LYTAC platform to develop therapeutics that degrade extracellular and membrane-bound proteins. Founded in 2019, the company has raised $75 million in Series D financing and is headquartered in South San Francisco.

• Oversee GCP quality systems and provide QA leadership for global clinical operations including decentralized trials.
• Lead investigations, CAPAs, risk assessments, and audits to ensure regulatory compliance.
• Review clinical documentation, support vendor qualification, and mentor QA staff.

WEP Clinical partners with biopharmaceutical sponsors to deliver clinical trial services, home health, and market access solutions. With over 15 years of global experience across 150+ countries, the company fosters a collaborative and mission-driven culture.

• Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
• Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
• Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.

• Acts as primary site contact and liaison for study management issues, ensuring compliance with ICH-GCP and regulatory requirements.
• Manages essential document collection, maintenance, and TMF organization, and coordinates investigator recruitment activities.
• Assists with data review, EDC entry, and supports offsite central monitoring and study supply management.

Precision Medicine Group is a clinical research organization providing services to pharmaceutical and biotech companies. The company has a global presence and fosters a collaborative culture focused on precision medicine.