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.
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.
Prepare and ensure completeness of Trial Master Files for internal and external studies.
Maintain the Trial Master File, creating file structure and indexing contents.
Communicate with client sponsors, project managers, monitors, and sites to ensure compliance.
Celerion is a performance-driven drug research company operating in the clinical research industry. They focus on integrity, trust, teamwork, and respect, offering a strong developmental environment.
Lead diverse CRO teams through Inspection Readiness preparation for a global oncology protocol. - Manage document retrieval in pTMF, ensuring all documents are present and correctly filed. - Coordinate with CROs to complete and update a ~500-item Inspection Readiness checklist.
Artech is an IT staffing company that provides technical expertise to fill gaps in clients' skill-set availability. As the 10th largest IT staffing company in the US, it offers flexible project planning and execution solutions.