Study Start Up Manager
Core
Manage and execute global clinical trial start-up activities, ensuring regulatory compliance and document quality for LATAM regions.
Role type
Senior Regulatory Submissions Manager (Clinical Trials)
Builds
Clinical trial start-up packages and regulatory submissions for biotech/pharma 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, Strategic problem solving
Technologies
Clinical trial management systems, Regulatory databases
Responsibilities
Manage global start-up execution, Perform quality checks on submission documents, Prepare and approve informed consent forms, Review regulations to solve start-up challenges, Present at bid defenses and audits
Seniority
Senior, hands-on IC