Roche
Healthcare
GlobalStudyLead(MolecularLab)
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optimal for Mid candidates.
“Global Study Lead (Molecular Lab) at Roche. Skills: Clinical trial management, Study design, Global regulations. Lead global cross-functional study team. Ensure high-quality study designs”
What You'll Achieve.
Prevent, stop and cure diseases; Ensure everyone has access to healthcare; Diagnose earlier; Develop faster; Personalise treatment; Improve healthcare outcomes; Get to patients faster; Generate comprehensive clinical evidence; Demonstrate product safety; Demonstrate product effectiveness; Demonstrate scientific validity; Facilitate smooth product registration; Facilitate product adoption; Facilitate product reimbursement; Save lives; Improve patient quality of life
Industry & Context.
Analytical clinical operations professional
What They're Looking For.
Must Have
Degree in Life Sciences, Healthcare, or a related scientific field, Strong, progressive experience in clinical trial management or study-level execution within the healthcare, pharmaceutical, or biotechnology sectors, Solid working knowledge of clinical research standards and global regulations (such as ICH-GCP, IVDD/IVDR, MDR, SaMD, or FDA frameworks), Demonstrated ability to manage external suppliers (like CROs) and successfully manage complex project budgets, Exceptional verbal and written communication skills in English
Nice to Have
Advanced degree, Experience study managing Molecular IVD clinical trials
What You'll Do.
Lead global cross-functional study team
Ensure high-quality study designs
Deliver clinical deliverables
Map innovative scenarios for evidence generation
Develop clinical documents
Oversee external service providers
Manage Contract Research Organisations (CROs)
Drive vendor performance
Manage vendor selection
Manage vendor relationships
Direct operational aspects of companion diagnostics studies
Manage early access portfolios
Manage research collaboration portfolios
Collaborate with international medical opinion leaders
Collaborate with investigators
Gather external insights
How You'll Work.
Team & Collaboration
Collaborate across Regulatory Affairs, R&D, and medical project teams; Collaborate with internal teams; Collaborate with external partners; Collaborate with patients; Work fluidly across diverse regions and cultures
Communication Scope
Exceptional verbal communication; Exceptional written communication; Build consensus
Process & Methodology
Clinical trial management, Study-level execution, Budget control, Timeline management, Vendor management, Project budgets
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 At **Roche Diagnostics Solutions (RDS),** our mission is clear: to diagnose earlier, develop faster, and personalise 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 digitalisation 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 the 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_** As a Global Study Lead, you will take full accountability for the design, planning, and execution of global sponsored clinical trials from protocol development through to close-out. Joining a dynamic, matrixed team within our Clinical Development and Medical Aff
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