Regulatory Submissions (Study Start-up) Manager
Core
Manage and execute global clinical trial start-up activities, including document preparation, quality checks, and regulatory submissions for biotechnology and pharmaceutical clients.
Role type
Senior IC Regulatory Submissions Manager (Clinical Operations)
Builds
Clinical Trial Applications (CTAs) and essential site documents for global trials
Domain
Clinical Research / Biotechnology / Pharmaceuticals
Required skills
Global start-up management, Clinical Trial Applications (CTA) knowledge, Regulatory compliance, Document quality assurance, Informed consent form preparation, Bid defense presentation
Preferred skills
CRO experience, CRA or project management background, European regulatory expertise
Technologies
Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), 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 challenges, Present at bid defenses and audits
Seniority
Senior, hands-on IC