Director, Clinical Risk Management Post Approval Delivery Unit

The Director, Clinical Risk Management – Post Approval Delivery Unit – oversees the overall risk management of a Disease Area Stronghold (DAS) or development phase. The role collaborates with CRM Representatives to coordinate the identification, assessment, and mitigation of quality risks that could impact trial data integrity, patient rights, safety, or well‑being. The director ensures the execution of data‑driven, risk‑based trial and program oversight activities that deliver quality in the execution of clinical trial programs, compliance with regulatory requirements and internal procedures, and a continued state of inspection readiness.

Responsibilities

• Establish goals and objectives for CRM Representatives.
• Conduct mid‑year and end‑of‑year reviews for CRM Representatives.
• Assist in outlining and evaluating career development goals with CRM Representatives.
• Coordinate workstreams to update processes for efficiency and maintain in...