Roche
Healthcare
ClinicalStudyManager
Neural analysis suggests this role is
optimal for Manager candidates.
“Clinical Study Manager at Roche. Skills: Clinical study operations, RWE activities, Cross-functional leadership. Lead study teams. Build cross-functional teams”
Industry & Context.
Solving complex operational problems
What They're Looking For.
Must Have
Proven clinical leadership experience, Experience leading study teams, Experience with secondary data use projects, Regulatory expertise, Practical experience applying global clinical quality requirements, Practical experience applying regulations, Practical experience applying pharmacovigilance standards, Strategic planning experience, Risk management experience, Experience managing trial budgets, Experience processing vendor agreements, Experience handling external system integrations, Exceptional communication skills
What You'll Do.
Build cross-functional teams
Guide cross-functional teams
Establish clear accountabilities
Establish deliverables
Establish psychologically safe environment
Manage end-to-end trial operations
Maintain comprehensive study plans
Maintain risk mitigation strategies
Maintain site selection procedures
Maintain vendor oversight protocols
Negotiate study agreements
Drive global regulatory compliance
Ensure adherence to international clinical trial guidelines
Ensure adherence to local regulations
Ensure inspection readiness
Direct vendor deliverables
Direct site deliverables
Maintain strict oversight of external vendors
Track vendor performance metrics
Resolve systematic operational issues
Organize necessary training
Develop strategic recruitment plans
Analyze trial feasibility data
Make data-driven recommendations
How You'll Work.
Team & Collaboration
Borderless study teams; Matrixed team environment; Cross-functional collaboration
Communication Scope
Written communication; Verbal communication; Present clear directions; Influence cross-functionally; Resolve conflicts
Process & Methodology
Study planning, Risk management, Budget management
Full Job Description
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 sys
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