Study Start-up and Regulatory Manager

Pedestal Health; Raleigh (NC); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work arrangement

Health, dental, and vision coverage

401(k) with company match

PTO and parental leave

Job summary

Pedestal Health in Research Triangle Park, NC, is seeking a Study Start-Up and Regulatory Manager to independently lead regulatory and start-up activities across multiple concurrent clinical studies.

You will manage IRB/IEC submissions, essential document collection, and TMF maintenance, ensure ICH-GCP and FDA compliance, coordinate translations, and maintain audit-ready records. This hybrid role requires three days in the office and two days remote.

Qualifications

• Bachelor's degree required.
• Minimum of 3 years of experience independently performing IRB submissions, essential document collection, and TMF maintenance.
• 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).

Responsibilities

• Independently prepare, execute, and manage IRB/IEC submissions for multiple concurrent studies.
• Lead study start-up and regulatory activities across Phase I-IV investigational, observational, and medical device submissions.
• Establish and maintain audit-ready TMFs in accordance with ICH-GCP, sponsor requirements, and regulatory guidelines.
• Coordinate translation of study documents to support multi-region and multi-language studies.
• Collect, review, and track essential regulatory documents at study/site start-up.
• Proactively track document expiration dates and renew documents throughout the study lifecycle.
• Liaise between sponsors, CROs, investigative sites, and IRBs/ECs to ensure timely submissions and issue resolution.
• Maintain regulatory tracking systems and provide status updates to teams and leadership.
• Ensure ongoing compliance with ICH-GCP, FDA regulations, and local/international requirements.
• Support contract and budget negotiations with sites as needed.

Skills

IRB submissions

TMF maintenance

ICH-GCP knowledge

FDA regulations

Project management

Communication skills

Hybrid work in RTP NC

Education

Bachelor's degree

Tools

Regulatory tracking systems

Job description

About Pedestal Health

Pedestal Health (formerly Target RWE) combines deep health system partnerships, longitudinal data curation at scale, and modern study design to build continuous, high-quality evidence for life sciences organizations. The company partners with pharmaceutical and biotech companies, providers and payers to generate rigorous, multimodal evidence that supports clinical, regulatory and strategic decision-making across the full lifecycle of care. Pedestal Health is committed to advancing medical decision making to improve outcomes for patients. Pedestal Health is a Highlander Health company. Learn more at pedestalhealth.com.

The Role

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.

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.

Pedestal Health is an equal opportunity employer and seeks candidates from diverse backgrounds and abilities.