The RolePedestal Health is seeking a Study Start-Up and Regulatory Manager to independently lead regulatory and start-up activities across a portfolio of concurrent clinical research projects. This individual will serve as the subject matter expert for IRB/IEC submissions, essential document collection, and Trial Master File (TMF) maintenance, ensuring studies are activated and maintained in full compliance with applicable regulations and audit-readiness standards.
What You'll Do- Independently prepare, execute, and manage IRB/IEC submissions, including initial submissions, continuing reviews, and amendments, across multiple concurrent studies.
- Lead study start-up and regulatory activities across Phase I-IV investigational (drug/biologic), observational, and medical device submissions.
- Establish and maintain audit-ready Trial Master Files (TMFs) in accordance with ICH-GCP, sponsor requirements, and applicable regulatory guidelines.
- Coordinate translation of study documents (e.g., informed consent forms and related materials) to support multi-region and multi-language studies.
- Collect, review, and track all essential regulatory documents required at study/site start-up (e.g., Form FDA 1572s, CVs, licenses, financial disclosures, IRB/IEC approvals, insurance certificates, and lab certifications).
- Proactively track document expiration dates and request updated or renewed documents throughout the life of the study to maintain continuous compliance.
- May serve as a liaison between sponsors, CROs, investigative sites, and IRBs/ECs to ensure timely regulatory submissions, approvals, and issue resolution.
- Maintain regulatory tracking systems and provide regular status updates to project teams and leadership.
- Ensure ongoing compliance with ICH-GCP, FDA regulations, and applicable local and international regulatory requirements.
- Support contract and budget negotiations with sites, as needed.
What You'll Bring- Bachelor's degree required.
- Minimum of 3 years of experience independently performing IRB submissions, essential document collection, and TMF maintenance or applicable experiences.
- Demonstrated experience supporting Phase I-IV investigational and observational submissions. Medical device experience is a plus.
- Working knowledge of ICH-GCP guidelines, FDA regulations, and IRB/IEC submission requirements.
- Strong organizational skills with the ability to independently manage multiple projects and competing priorities.
- Excellent written and verbal communication skills.
- Ability to work in a hybrid environment based in Research Triangle Park, NC (3 days in office, 2 days remote).
Nice to Have- Experience with contract and budget negotiation is a plus but not required.
- Experience supporting medical device submissions is a plus but not required.
What We Offer You- Hybrid work arrangement, with regular onsite collaboration at a Pedestal Health office
- Comprehensive health, dental, and vision coverage
- 401(k) with company match
- Generous PTO and paid parental leave
If you are ready to be part of a team where your work truly matters-where your expertise is valued, your growth is supported, and your contributions help shape the future of healthcare-Pedestal Health is the place for you. We're building something meaningful together, and we'd love for you to be a part of it.
