Clinical Study Manager
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About the Role
Lead operational execution of clinical studies, manage trial operations, ensure regulatory compliance, and develop recruitment plans with strong leadership and communication ski.
Key Skills for This Role
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Overview
At Roche you can show up as yourself, embraced for the unique qualities you bring.
Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.
Join Roche, where every voice matters.
The Position We are seeking a Clinical Study Manager to lead the operational execution of our secondary data use Real World Evidence (RWE) activities and international clinical studies.
In this role, you will coordinate end-to-end study operations across global sites, ensuring that our clinical programs deliver high-quality data safely, efficiently, and ethically.
You will work within a highly collaborative, matrixed team environment where your leadership directly helps us bring medical innovations to patients faster.
Your Responsibilities
- Lead Study Teams: Build and guide cross-functional, borderless study teams, establishing clear accountabilities, deliverables, and a psychologically safe environment where everyone can thrive.
- Manage End-to-End Trial Operations: Maintain comprehensive study plans, risk mitigation strategies, site selection procedures, and vendor oversight protocols from activation through to clinical closure.
- Oversee Financials & Agreements: Manage study budgets, track metrics, review work orders, and negotiate study agreements to ensure highly cost-effective operations with minimal variances.
- Drive Global Regulatory Compliance: Ensure absolute adherence to international clinical trial guidelines (such as Good Pharmacovigilance Practices and Good Pharmacoepidemiology Practices), relevant local regulations, and inspection readiness.
- Direct Vendor & Site Deliverables: Maintain strict oversight of external vendors, tracking performance metrics, resolving systematic operational issues, and organizing necessary training.
- Develop Strategic Recruitment Plans: Analyze trial feasibility data across multiple countries to make data-driven recommendations on site distribution, patient numbers, and retention strategies.
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