indeed
Global Study Manager
Alexion Pharmaceuticals
Mississauga, CAN
Temporary
Hybrid
Discovered 3 weeks ago
Global clinical trial managementClinical researchClinical Study Protocol developmentVendor oversightCRO managementStudy budget management
Free
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Global clinical trial managementClinical researchClinical Study Protocol development
Role Overview
The Global Study Manager is part of Development Operations and the global study team.
The role supports clinical studies from protocol development through setup, maintenance, close-out, Clinical Study Report development, and archiving.
Studies may span multiple therapeutic areas and phases I through IV, including late phase, non-interventional, registries, and early access programs.
Key Skills for This Role
Global clinical trial managementClinical researchClinical Study Protocol developmentVendor oversightCRO managementStudy budget management
Full Job Posting
Role overview
The Global Study Manager is part of Development Operations and the global study team.
The role supports clinical studies from protocol development through setup, maintenance, close-out, Clinical Study Report development, and archiving.
Studies may span multiple therapeutic areas and phases I through IV, including late phase, non-interventional, registries, and early access programs.
Workplace
- The role generally operates in an office environment.
- Employees work from the office an average minimum of three days per week while retaining individual flexibility.
Study delivery responsibilities
- Oversee vendors and delegated study activities according to timelines, budgets, quality standards, and documented oversight requirements.
- Coordinate with Data Management, Procurement, Regulatory, Patient Safety, Quality Assurance, CROs, and other service providers.
- Plan and conduct investigator, monitor, internal, and external study meetings.
- Support budget management and maintain global study management plans and related documents.
- Perform Study Lead activities for less-complex studies and delegate team responsibilities.
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