Global Study Manager – FSP – EMEA

About the role

The Global Study Manager (GSM) – FSP – EMEA will be embedded within a leading bio‑pharma client, overseeing the end‑to‑end delivery of clinical studies across multiple regions. The role is responsible for planning, executing and archiving studies while ensuring quality, timelines and budget compliance.

Key responsibilities

• Develop and drive the Clinical Study Activity Plan, Study Delivery Plan and TM & F quality strategy.
• Lead study initiation meetings, investigator/CRA meetings and related training.
• Oversee DCT set‑up, vendor selection, CRO management and vendor oversight plans.
• Manage recruitment, budget tracking, eTMF filing and safety management plans.
• Identify, monitor and mitigate study risks, ensuring clear stakeholder communication.
• Provide operational input to protocol, informed consent form and other key study documents.
• Lead investigator meetings, quality initiatives and inspection readiness activities.
• Coordinate activities across participating countries (NA, EMEA, APAC, LATAM, etc.).

Required profile

• Bachelor’s degree in life sciences or a related discipline.
• 5 + years of global study management experience, including Phase II‑III oncology studies.
• Demonstrated cross‑functional leadership and experience managing matrix teams.
• Experience with regulatory inspections (FDA, EMA, MHRA, PMDA) is an asset.
• Exposure to multiple regions (NA, EMEA, APAC, LATAM) and familiarity with China/Japan markets is a plus.

Required skills

• Clinical study management
• Monitoring and data management
• Oncology clinical research
• Clinical budget management
• Vendor and CRO management
• Clinical risk management
• Clinical systems proficiency