- Provide Clinical QA oversight for new and ongoing clinical studies to ensure compliance with GCP and regulatory requirements.
- Manage clinical deviations, investigations, root cause analysis, CAPA development, and change control.
- Conduct and manage investigator site, vendor, study-specific, and for-cause audits.
- Develop and execute a phase-appropriate GCP audit strategy and annual audit program.
- Lead GCP inspection readiness activities and support global regulatory inspections, including FDA BIMO.
- Support qualification, selection, and ongoing oversight of CROs and GCP-relevant vendors.
- Provide quality oversight for TMF health and inspection-ready documentation practices.
- Collaborate with clinical operations and development functions to assess and mitigate quality risks.
GCP