Roche
Healthcare
GlobalStudyLead
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optimal for Lead candidates.
“Global Study Lead at Roche. Skills: Global study leadership, Clinical trial execution, Regulatory knowledge. Lead global study teams. Manage timelines”
What You'll Achieve.
High-quality clinical trial deliverables
Industry & Context.
Complex problem resolution
What They're Looking For.
Must Have
Bachelor's degree in Life Sciences, Minimum 5 years global clinical operational experience, Expertise managing clinical study development phases, Deep working knowledge of international clinical regulations, Agile communicator and collaborative leader, Ability to resolve complex problems, Ability to build cross-functional consensus, Ability to guide project teams
Nice to Have
Experience with IVDD/IVDR, Experience with MDR, Experience with FDA guidelines
What You'll Do.
Lead global study teams
Manage milestone execution
Manage multi-million dollar budgets
Design operational study strategies
Execute operational study strategies
Develop study documentation
Validate study documentation
Deliver operational oversight
Manage international clinical vendor portfolios
Lead vendor selection processes
Drive vendor execution
Build partnerships with investigators
Build partnerships with opinion leaders
Build partnerships with global alliance partners
How You'll Work.
Team & Collaboration
Cross-functional collaboration; International medical investigators; Opinion leaders; Global alliance partners; Clinical Development teams; Regulatory Affairs teams; Research & Development teams
Communication Scope
Agile communication
Process & Methodology
Timeline management, Milestone execution, 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 **Who We Are** At **Roche Diagnostics Solutions (RDS)** , our mission is clear: to diagnose earlier, develop faster, and personalize treatment because every patient is unique. Our **Clinical Development & Medical Affairs (CDMA) **team drives innovation to improve healthcare outcomes globally. We see ourselves and our customers as a team that can only reach its full potential together. By listening closely to patients and physicians, and leveraging digitalization and new technologies, we get closer to their real-world needs. This collaborative spirit creates an environment where ideas can grow and new ways of doing things can be tried - resulting in competitive products that get to patients faster. Our work spans the entire product lifecycle, from discovery to post-launch. By collaborating with internal teams, external partners, and patients, the CDMA chapter provides crucial medical insights, designs and executes clinical studies, and offers on-market support. Ultimately, we generate comprehensive clinical evidence that demonstrates product safety, effectiveness, and scientific validity - facilitating smooth product registration, adoption and reimbursement globally so we can save lives and improve patient quality of life. ****The Opportunity**** * Lead global study teams with full accountability for high-quality clinical trial deliverables, managing timelines, milestone execution, and multi-million-dollar clinical budgets. * Design and execute innovative global operational study strategies in
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