Clinical Operations and Study Leader
Core
Leads clinical project and study oversight for vaccines, ensuring deliverables are on time and within budget while coordinating cross-functional teams and external stakeholders.
Role type
Senior Clinical Operations and Study Leader
Builds
Clinical development plans, regulatory submissions (CTD, PAI), and study execution strategies
Domain
Biopharmaceuticals / Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical project management, regulatory submission expertise, cross-functional leadership, risk management, budget management, crisis management, vendor management, strategic communication
Preferred skills
Innovation in clinical trial design, digital methodologies, mentorship, global/regional coordination
Technologies
CSC Order Management tool, Trial Management tools
Responsibilities
Develop operational strategies for clinical projects, coordinate study execution and timelines, manage project budgets and resources, lead risk and crisis management, oversee regulatory submissions, manage vendor relationships, facilitate cross-functional communication
Seniority
Senior, hands-on IC with leadership responsibilities
