Regulatory Start-Up Lead for Clinical Trials

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

Benefits offered by this job

Health, dental and vision coverage

401(k) with company match

Generous PTO and parental leave

Job summary

Pedestal Health is seeking a Study Start-Up and Regulatory Manager to lead regulatory and start-up activities for multiple clinical research projects. You will act as the SME for IRB/IEC submissions, essential documents, and TMF maintenance, ensuring activation and audit readiness in compliance with applicable regulations.

You will manage submissions across Phase I–IV, coordinate document translations, and maintain regulatory tracking systems, while collaborating with sponsors, CROs, and sites

Qualifications

• Bachelor's degree required.
• Minimum of 3 years of experience independently performing IRB submissions, essential document collection, and TMF maintenance.
• Working knowledge of ICH-GCP guidelines, FDA regulations, and IRB/IEC submission requirements.
• Excellent written and verbal communication skills.

Responsibilities

• Independently prepare, execute, and manage IRB/IEC submissions across multiple concurrent studies.
• Lead start-up and regulatory activities across Phase I–IV and other submissions.
• Maintain audit-ready TMFs in line with ICH-GCP and sponsor requirements.
• Coordinate translation of study documents for multi-region studies.
• Track essential regulatory documents (Form FDA 1572s, CVs, licenses, disclosures, IRB/IEC approvals).
• Monitor document expirations and renewals to ensure ongoing compliance.

Skills

Regulatory knowledge

Project management

Documentation accuracy

Communication skills

Hybrid work coordination

Education

Bachelor's degree

Job description

Pedestal Health is seeking a Study Start-Up and Regulatory Manager to lead regulatory and start-up activities for multiple clinical research projects. You will act as the SME for IRB/IEC submissions, essential documents, and TMF maintenance, ensuring activation and audit readiness in compliance with applicable regulations.

You will manage submissions across Phase I–IV, coordinate document translations, and maintain regulatory tracking systems, while collaborating with sponsors, CROs, and sites