About the position
Pedestal 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.
Responsibilities
• 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.
Requirements
• 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.
• 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.
Nice-to-haves
• Medical device experience is a plus.
• Experience with contract and budget negotiation is a plus but not required.
• Experience supporting medical device submissions is a plus but not required.
Benefits
• Comprehensive health, dental, and vision coverage
• 401(k) with company match
• Generous PTO and paid parental leave