Oversees the planning, execution, and close-out of clinical research studies for single and multi-site studies
Ensures operational excellence, regulatory compliance, and timely delivery of study milestones
Leads cross-functional teams through all phases of clinical trial execution, including study start-up, conduct, and close-out phases
Develops and manages project timelines and deliverables
Monitors progress against milestones and proactively addresses risks or delays
Tracks enrollment metrics, protocol deviations, and site performance
Optimizes resource allocation and capacity planning
Serves as primary contact for sponsors and external vendors
Coordinates with sponsors, CROs, and internal teams to ensure alignment
Facilitates communication across teams by conducting regularly scheduled team meetings
Manages project according to Operational Study Plans (Project Management Plan, Monitoring Plan, Clinical Site Blinding Plan, etc.)
Supports audit readiness and maintains complete, compliant documentation.

Bachelor’s degree in life sciences or related field
4+ years of clinical research experience (Project Management experience preferred)
ACRP certification a plus
Strong knowledge of FDA regulations and ICH GCP
Proficiency in SharePoint, Excel, and project management tools
Experience with multi-site trials and sponsor/CRO collaboration, preferred
Familiarity with MedDRA coding and pharmacovigilance workflows.

Sponsor Research Division Project Manager

Key skills