Study Start-Up Project Manager
Core
Manage the full lifecycle of clinical trial start-up, maintenance, and close-out, serving as the primary contact for regulatory submissions and business development proposals.
Role type
Senior Study Start-Up Project Manager
Builds
Clinical trial infrastructure and regulatory submissions for biotechnology, pharmaceutical, and medical device clients
Domain
Clinical Research / Contract Research Organization (CRO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial management, regulatory compliance, project management, team leadership, business proposal development, quality assurance
Preferred skills
Advanced degree in Life Sciences, CRO experience, Research Manager experience
Technologies
Clinical trial management systems, regulatory submission platforms
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; Serve 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
