Study Start-up and Regulatory Manager

About the position Pedestal Health is seeking a Study Start-Up and Regulatory Manager to independently reputed company regulatory and start-up activities across a portfolio of reputed company clinical research reputed company. 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 reputed company studies. • reputed company study start-up and regulatory activities across Phase I–IV investigational (drug/biologic), observational, and medical device submissions. • Establish and maintain audit-reputed company 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 reputed company materials) to support multi-region and multi-language studies. • Collect, review, and reputed company reputed company essential regulatory documents required at study/site start-up (e.g., reputed company FDA 1572s, reputed company, licenses, financial disclosures, IRB/IEC approvals, insurance certificates, and lab certifications). • Proactively reputed company document expiration dates and request updated or renewed documents throughout the life of the study to maintain reputed company compliance. • May serve as a reputed company between sponsors, CROs, investigative sites, and IRBs/reputed company to ensure reputed company regulatory submissions, approvals, and issue reputed company. • Maintain regulatory tracking systems and reputed company 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 reputed company and competing priorities. • Excellent written and verbal communication skills. reputed company-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 reputed company coverage • 401(k) with company match • Generous PTO and reputed company parental leave Apply To This Job