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 leading cross-functional teams.
Key Skills for This Role
Responsibilities
- Lead Study Teams: Build and guide cross functional, borderless study teams, establishing clear accountabilities, deliverables, and a psychologically safe environment.
- 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 cost effective operations.
- Drive Global Regulatory Compliance: Ensure adherence to international clinical trial guidelines (e.g., GVP, GPP) and local regulations, and maintain inspection readiness.
- Direct Vendor & Site Deliverables: Maintain oversight of external vendors, track performance metrics, resolve operational issues, and organize 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.
Requirements
- Demonstrated experience leading successful study teams through all operational stages of clinical studies or secondary data use projects
- Clear understanding and practical experience applying global clinical quality requirements, regulations, and pharmacovigilance standards
- Strong organizational awareness with a proactive planning mindset, including ability to embed operational contingencies
- Experience successfully managing trial budgets, processing vendor agreements, and handling external system integrations
- Well developed written and verbal communication skills, with proven ability to present clear directions, influence cross functionally, and resolve conflicts
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.
- 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.
Who You Are
- You are a proactive, strategic operational leader with a passion for clinical excellence and cross functional collaboration.
- You bring a growth mindset, excel at solving complex operational problems under tight deadlines, and possess deep listening and empathy skills that inspire your teams.
To be successful in this role, you bring:
- Proven Clinical Leadership: Demonstrated experience leading successful study teams through all operational stages of clinical studies or secondary data use projects.
- Regulatory Expertise: A clear understanding and practical experience applying global clinical quality requirements, regulations, and pharmacovigilance standards.
- Strategic Planning & Risk Management: Strong organizational awareness with a proactive planning mindset, including the ability to embed operational contingencies.
- Financial & Vendor Acumen: Experience successfully managing trial budgets, processing vendor agreements, and handling external system integrations.
- Exceptional Communication: Well developed written and verbal communication skills, with a proven ability to present clear directions, influence cross functionally, and resolve conflicts.
Compensation & Benefits
- This position also offers an attractive benefits package.
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