Identify, source, and manage clinical vendor relationships to support study objectives and cost-effective procurement.
Review clinical protocols to determine vendor scope, lead RFPs, and negotiate contracts with legal and finance teams.
Monitor vendor performance, resolve issues, and drive continuous improvement across clinical operations.
Care Access brings world-class clinical research and health services directly to communities, with hundreds of locations and clinicians globally. They are dedicated to building a more accessible future of health, emphasizing people at the heart of medical progress.
Oversee day-to-day management of third-party vendors throughout clinical study lifecycle.
Develop and implement vendor oversight plans and monitor performance through KPIs and governance meetings.
Facilitate cross-functional collaboration to resolve issues and ensure compliance with GCP and regulatory requirements.
The company is a clinical research organization that manages clinical trials and third-party vendors. The team size is not specified, but the culture is collaborative and quality-focused.
Manage operational activities for all phases of clinical studies, from start-up to close-out.
Provide sponsor oversight of CROs and vendors to ensure compliance and quality.
Support data review, TMF maintenance, and cross-functional collaboration for trial success.
Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company developing off-the-shelf cell therapies for devastating diseases. The company fosters an open, collaborative culture where diverse perspectives are welcomed, with teams working from Berkeley or remotely.
Lead operational execution of cell therapy trials from startup through close-out, managing timelines, budgets, and vendor oversight.
Ensure compliance with regulatory standards including FDA, EMA, and ICH-GCP, and contribute to protocol development and study documents.
Collaborate cross-functionally with clinical operations, data management, regulatory, and manufacturing teams to drive study success.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. They are guided by core values of collaboration and innovation, fostering a culture of ownership and clarity.
Lead TMF operations across clinical studies to ensure timely, complete, and inspection-ready documentation in compliance with ICH-GCP and regulatory standards.
Establish TMF governance, monitor quality metrics, and communicate findings to study teams and leadership.
Partner cross-functionally to drive process improvements and strategic oversight of CRO-managed TMF activities.
BridgeBio pioneers a 'moneyball for biotech' approach, pooling early-stage research to reduce risk and accelerate innovation for life-changing medicines. They foster a culture of curiosity and experimentation with a focus on ethics.
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.