Sr. Study Management Specialist
Core
Manage and lead complex clinical studies (NIS, PMOS, IIS, PAA) from design through closeout, ensuring quality, compliance, and delivery of study objectives.
Role type
Senior Study Management Specialist
Builds
Clinical study deliverables including protocols, reports, and regulatory submissions
Domain
Pharmaceutical clinical research
Required skills
Study lifecycle management, vendor/CRO/site selection, budget management, regulatory compliance (GCP), protocol development, stakeholder communication, risk management
Preferred skills
NIS experience, project management, process improvement
Technologies
MS Word, MS Excel, PowerPoint
Responsibilities
Lead end-to-end operational management of assigned studies, manage study budgets and investigator payments, oversee study start-up and site selection, serve as operational point of contact for regulatory submissions, provide guidance on study management processes
Seniority
Senior, hands-on IC