Study Start Up Manager
Core
Manage and execute all aspects of global clinical trial start-up, including regulatory submissions, site document quality checks, and informed consent form preparation.
Role type
Senior Regulatory Submissions Manager (Clinical Trial Start-Up)
Builds
Clinical trial start-up packages for biotechnology, pharmaceutical, and medical device clients
Domain
Clinical Research / Regulatory Affairs
Required skills
Regulatory submissions management, Clinical Trial Applications (CTA) knowledge, Quality assurance, Informed consent form preparation, Bid defense presentation, Team leadership
Preferred skills
Latam regulatory expertise, Life science degree background
Technologies
Clinical Trial Applications (CTA), Regulatory submission platforms
Responsibilities
Manage global start-up execution, Perform quality checks on submission and site documents, Prepare and approve informed consent forms, Review regulations to solve start-up issues, Present at bid defenses and audits
Seniority
Senior, hands-on IC