Study Start-up and Regulatory Manager

Pedestal Health•Raleigh, NC

16h•Hybrid

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.

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.

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.