Project Manager
Core
Manages clinical research studies to ensure compliance with ICH GCP guidelines and FDA regulations, serving as the primary contact for sponsors.
Role type
Senior Clinical Project Manager
Builds
Clinical research studies and trial milestones
Domain
Pharmaceutical / Biotechnology / CRO industry
Deliverable
client delivery
Required skills
Clinical study management, ICH GCP compliance, FDA regulation knowledge, budget management, team supervision, protocol creation, TMF management, audit preparation, subject accrual management
Preferred skills
Life sciences background, management experience, problem-solving in ambiguous environments
Technologies
MS Office Suite (Word, Excel)
Responsibilities
Manage clinical research studies within scope, budget, and timelines; serve as study lead and primary sponsor contact; supervise Clinical Assistants and Research Associates; create and review clinical study documents; drive clinical teamwork and communications; prepare for third-party audits and FDA inspections; manage subject accrual and retention.
Seniority
Senior, hands-on IC with management responsibilities
