Manager, Clinical Risk Management

About the role

The Manager, Clinical Risk Management leads the identification, assessment and mitigation of quality risks across clinical trials and programs. Working with trial and program teams, the role ensures data integrity, patient safety and regulatory compliance while maintaining inspection readiness.

Key responsibilities

• Participate in study activities to identify and assess key protocol risks and advise on mitigation strategies.
• Lead regular risk reviews with Risk Owners, track mitigation progress and update Clinical Quality Plans.
• Drive quality risk monitoring, coach teams on risk assessment and communicate updates through Quality Working Groups and governance forums.
• Provide guidance on significant quality issues, support CAPA development and effectiveness checks.
• Coordinate inspection readiness activities, develop inspection narratives and support pre‑inspection visits and mock inspections.

Required profile

• Minimum Bachelor’s degree in a scientific, medical or related discipline.
• At least 8 years of experience in the pharmaceutical, CRO or healthcare sector.
• Strong knowledge of GCP, ICH guidelines and clinical trial quality standards.
• Proven ability to work in culturally diverse, cross‑functional environments.
• Fluency in English, both spoken and written.

Required skills

• Microsoft Office applications.
• Data analytics and visualization tools such as Tableau or Spotfire.
• Good Clinical Practice (GCP) and ICH guideline implementation.
• Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GPvP) knowledge.
• Health authority inspection experience (FDA, EMA).
• CAPA development and effectiveness verification.
• Project planning and management.