Position
Global Study Lead within Roche Diagnostics Solutions (RDS) Clinical Development & Medical Affairs (CDMA) team, responsible for design, planning, and execution of global sponsored clinical trials.
Responsibilities
- Lead global cross‑functional study team with full accountability for study designs, clinical deliverables, budgets, and timelines.
- Collaborate with Program Leadership to map innovative global evidence scenarios, coordinating with Regulatory Affairs, R&D and medical project teams.
- Develop clinical documents including study protocols, Design Validation Plans, study forms, and comprehensive study reports.
- Oversee external service providers and CROs, driving vendor performance, selection, and relationship management at the study level.
- Direct operational aspects of companion diagnostics studies and early access / research collaboration portfolios.
- Collaborate with international medical opinion leaders, investigators and key external stakeholders to incorporate external insights.
- Ensure operational excellence, budget control, and inspection readiness across diverse study portfolios.
Qualifications
- Degree in Life Sciences, Healthcare, or related scientific field (advanced degree is a plus).
- Strong, progressive experience in clinical trial management or study-level execution within healthcare, pharmaceutical or biotechnology sectors.
- Preferably experience managing molecular IVD clinical trials.
- Solid knowledge of clinical research standards and global regulations (ICH‑GCP, IVDD/IVDR, MDR, SaMD, or FDA frameworks).
- Demonstrated ability to manage external suppliers, including CROs, and successfully manage complex project budgets.
- Exceptional verbal and written communication skills in English, with proven ability to lead project substreams, build consensus, and work fluidly across diverse regions and cultures.
Location
Primary location: Burgess Hill. Additional locations may be discussed during the hiring process.
EEO Statement
All qualified applicants will receive consideration for employment without regard to race, religion, belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability, or age. We recognize the importance of flexible working and will review all applicants’ requests with care.
