Study Start-Up Project Manager
Core
Manage the full lifecycle of clinical trial start-up, maintenance, and close-out for biopharma clients.
Role type
Senior clinical trial project manager (study start-up)
Builds
Clinical trial operations for biotechnology, pharmaceutical, and medical device companies
Domain
Clinical research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
Clinical trial management, regulatory compliance, document quality assurance, informed consent form preparation, business proposal development, team leadership, matrix environment navigation
Preferred skills
Advanced degree in Life Sciences, prior CRO study start-up experience, site research manager experience
Technologies
Clinical trial management systems (implied via document management and regulatory submissions)
Responsibilities
Manage execution of clinical trial start-up, maintenance, and close-out; Lead teams in a matrix environment; Perform quality checks on submission and site documents; Prepare and approve informed consent forms; Act as Sponsor point of contact for regulatory submissions; Review regulations to solve start-up challenges; Prepare and present new business proposals; Contribute to staff and process development
Seniority
Senior, hands-on IC with leadership responsibilities
