Regional Clinical Study Manager
New
B
BeOneClinical research
Remote (US)Full-TimeManager
Salary$136,400.00 - $181,400.00 annually
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Job Details
- Experience
- 6 or more years of progressive experience in clinical research within biotech, pharma or CRO industry
- Required Skills
- MS Office
Requirements
- At least 6 years of progressive clinical research experience in biotech, pharma, or CRO settings.
- Proven clinical research experience, including relevant team-lead experience in clinical functions.
- Bachelor’s degree in a scientific or healthcare discipline; exceptions may be made for relevant clinical operations experience.
- A higher degree is preferred.
- CRA experience is preferred.
- Experience with MS Office and project planning applications.
- Travel may be required based on business needs.
Responsibilities
- Lead regional clinical operations teams and external vendors, resolving escalated study issues.
- Coordinate regional stakeholders and report study progress to senior management and the Global Clinical Study Manager.
- Plan and manage regional study activities from feasibility through closeout against global timelines.
- Drive regional trial feasibility, country allocation, site selection, and study start-up and recruitment timelines.
- Coordinate local adaptations of global study documents and regional country submissions.
- Maintain current regional and country information in study systems and tools.
- Work with CRAs to support site execution and review and sign off monitoring reports.
- Ensure country- and site-level Trial Master Files are maintained and quality checked.
- Monitor compliance, inspection readiness, audit preparation, and responses to findings.
- Manage regional study budgets, vendors, and team resource needs.
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