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Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Global Study Manager II
Location
Canada
Posted
55 days ago
Salary
0
Seniority
Lead
Job Description
Global Study Manager II
Parexel
• Provides operational leadership throughout the study lifecycle • Leads and coordinates the execution of a clinical trial globally from sourcing strategy and study specification development for requests for proposals to fully outsourced studies and ancillary vendors • Provides quality oversight and coordination of regional and country operations • Reviews consolidated pre-trial assessment (PTA) reports and feasibility outputs • Ensures overall vendor oversight for vendors managed by SOMs • Accountable for study management and oversight of all study management functions • Develops and provides key inputs to clinical trial budget • Ensures timely study closure and release of internal and external resources as appropriate if assigned to study post database lock • Serves as technical expert for study management systems and processes
Job Requirements
- Experience in clinical research and/or study management
- Study management/leadership experience
- Experience with oversight of CROs and vendors
- Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend
- Fluency in written and spoken English required.
- Ability to work outside of core business hours, as required, to support global trials or initiatives
- Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings
- Exceptional knowledge of study management processes and deliverables
- Good knowledge in understanding the responsibilities beyond their function to ensure goals are met for the study
- Maintains expertise within the assigned therapeutic area and study to set the appropriate strategy, identify risks and to drive operational deliverables
- Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations
Benefits
- Competitive salary
- Flexible working hours
- Professional development budget
- Home office setup allowance
- Global team events
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