R&D Clinical Operations Sci Assoc Prin Scientist
Core
End-to-end management of clinical trials from planning through close-out, ensuring timelines, budget, and quality while maintaining regulatory compliance.
Role type
Senior Principal Scientist, Clinical Operations
Builds
Clinical trials for PepsiCo R&D, including internal studies and external partnerships
Domain
Life Sciences / Clinical Research / Real-World Evidence (RWE)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial methodology, GCP/ICH regulatory compliance, Vendor management (CROs/AROs), Protocol development, Budget management, Monitoring plan development, Data review
Preferred skills
Real-World Evidence (RWE) studies, Digital/decentralized trial designs, Site selection, Clinical supplies logistics
Technologies
Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), (e)CRFs
Responsibilities
Manage external vendors (CROs, AROs, clinical sites, Central Labs, IRBs), Write and finalize study protocols and regulatory documents, Conduct monitoring visits and review site reports, Track subject recruitment and trial progress, Manage trial budgets and contracts, Coordinate clinical supplies logistics, Provide GCP training to internal and external teams
Seniority
Senior, hands-on IC
