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Posted 3w agoResearch Triangle Park, North Carolina

Study Start-up and Regulatory Manager

MiddleOn-site (Research Triangle Park)Salary undisclosed
Required Skills
GCP
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 submissio

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