Regulatory Submissions (Study Start-up) Manager
Core
Manage and execute global clinical trial start-up activities, ensuring regulatory compliance and document quality for new studies.
Role type
Senior Regulatory Submissions Manager (Clinical Operations)
Builds
Global clinical trial start-up packages and regulatory submissions
Domain
Clinical Research / CRO / Biopharma
Required skills
Clinical trial start-up management, Clinical Trial Applications (CTA) knowledge (Europe), Regulatory review, Document quality assurance, Informed consent form preparation, Bid defense presentation
Preferred skills
CRO experience, CRA or project management background
Technologies
Clinical Trial Applications (CTA), Informed Consent Forms (ICF)
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 with leadership
