Study Start-up and Regulatory Manager

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; 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; Ability to work in a hybrid environment based in Research Triangle Park, NC (3 days in office, 2 days remote)

Nice to have

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

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