Global Study Manager – Single Sponsor (EMEA)

About the role

The Global Study Manager (GSM) is a key member of the extended global study team, responsible for delivering clinical studies for a biopharmaceutical organization across the EMEA region. The role covers the full study lifecycle from protocol development through set‑up, execution, close‑out, report writing and archiving.

Key responsibilities

• Prepare and review delegated study documents such as Informed Consent Forms and master Clinical Study Agreements.
• Coordinate with internal functions and external service providers, including CROs, to ensure timely, cost‑effective, and high‑quality study delivery.
• Organise and support internal and external meetings, including investigators’ and monitors’ meetings.
• Manage investigational product supply by liaising with Clinical Supply Chain and external partners.
• Identify risks and issues, develop mitigation plans, and ensure study documents are complete and quality‑checked in the Trial Master File.
• Assist Global Study Director/Associate Director with budget management and invoice reconciliation.
• Ensure compliance with global clinical processes, SOPs, ICH/GCP guidelines and maintain inspection readiness.
• Oversee CRO Project Managers for outsourced studies, maintaining appropriate oversight and documentation.

Required profile

• University degree (or equivalent) in medical, biological sciences or a related discipline.
• Relevant experience within the pharmaceutical industry or a comparable organization.

Required skills

• ICH/GCP compliance
• Trial Master File (TMF) management
• CRO oversight and management
• Clinical supply chain coordination
• Budget and invoice reconciliation

What we offer

• Opportunity to work on global, sponsor‑driven clinical studies.
• Collaboration with cross‑functional internal and external partners.
• Exposure to the full clinical study lifecycle across the EMEA region.