Experienced Study Start-Up Project Manager (Remote)
Core
Manage the global execution of clinical trial start-up, maintenance, and close-out processes to accelerate the development of medical therapeutics.
Role type
Senior Clinical Study Start-Up Project Manager
Builds
Global clinical trial studies for biotechnology, pharmaceutical, and medical device clients
Domain
Clinical Research / Contract Research Organization (CRO)
Required skills
Global study start-up management, matrix team leadership, regulatory compliance, informed consent form preparation, bid defense presentation, process optimization
Preferred skills
Advanced degree in Life Sciences, experience in oncology, cardiology, or metabolic therapeutic areas
Technologies
Clinical trial management systems, regulatory submission platforms
Responsibilities
Manage successful execution of global start-up, maintenance, and close-out studies; Lead others in a matrix environment; Perform quality checks on submission and site essential documents; Prepare and approve informed consent forms; Serve as Sponsor point of contact for regulatory submissions; Review regulations to develop proactive solutions to start-up challenges; Prepare new business proposals and present during bid defenses and audits; Contribute to the growth and development of departmental staff and systems
Seniority
Senior, hands-on IC
