Global Study Lead - FSP - EMEA - Managed Access Program Experience
Thermo Fisher Scientific · Remote
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Role summary
Thermo Fisher Scientific seeks an experienced Global Study Lead to provide strategic and operational leadership for clinical studies and programs within a functional service partnership with GSK. The role emphasizes managing Managed Access Programs in the EMEA region, with accountability for timelines, quality, budget, and compliance.
What they're looking for
- Significant clinical research and development experience in pharmaceutical, biotechnology, or CRO settings
- Proven track record at Global Study Lead, Global Trial Lead, or Senior Clinical Trial Manager level
- Previous leadership or operational oversight of Managed Access Programs in UK and/or EMEA region
- Experience leading complex global studies with accountability for operational delivery across geographies
- Demonstrated ability to lead high-performing, cross-functional, matrix-organized teams
- Strong knowledge of global clinical development, regulatory processes, and ICH-GCP requirements
- Proven experience managing study timelines, budgets, risks, and quality standards
What you'll be doing
- Provide strategic leadership and operational accountability for assigned studies from initiation through completion and archiving
- Lead and oversee Managed Access Programs, ensuring effective delivery across UK and EMEA regions
- Act as Clinical Operations escalation point and key member of Study Leadership Team for strategic decision-making
- Lead cross-functional study teams and oversee CRO and vendor performance management
- Develop operational plans, identify and mitigate risks, and maintain compliance with regulatory requirements and company standards
Privacy & handoff
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