Regulatory Submissions (Study Start-up) Manager
Core
Manage and execute global clinical trial start-up activities, ensuring quality of submission documents and informed consent forms while developing proactive solutions to regulatory challenges.
Role type
Senior IC Regulatory Submissions Manager (Study Start-up)
Builds
Clinical trial start-up packages for biotechnology, pharmaceutical, and medical device clients
Domain
Clinical Research / Regulatory Affairs / Life Sciences
Required skills
Global clinical trial 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 Applications (CTA), Informed Consent Forms (ICF)
Responsibilities
Manage global start-up execution per Sponsor specifications, 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