Clinical Study Manager
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Key skills for this role
About the Role
Roche is seeking a Clinical Study Manager to lead operational execution of secondary data use Real World Evidence activities and international clinical studies. The role involves coordinating end-to-end study operations, managing budgets, ensuring regulatory compliance, and overseeing vendors.
Key Skills for This Role
Responsibilities
- Lead cross functional study teams, establishing clear accountabilities and deliverables
- Manage end to end trial operations including study plans, risk mitigation, site selection, and vendor oversight
- Oversee financials and agreements, manage budgets, track metrics, and negotiate study agreements
- Drive global regulatory compliance with GVP, GPP, and local regulations
- Direct vendor and site deliverables, track performance metrics, and resolve operational issues
- Develop strategic recruitment plans using feasibility data across multiple countries
Requirements
- Experience in clinical study management and operational execution
- Knowledge of global regulatory compliance and clinical trial guidelines (GVP, GPP)
- Ability to manage budgets and negotiate study agreements
- Experience with vendor oversight and performance tracking
Full Job Posting
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.
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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