Study Start-up and Regulatory Manager
Core
Lead regulatory and start-up activities for a portfolio of concurrent clinical research projects, ensuring studies are activated and maintained in full compliance with regulations.
Role type
Study Start-Up and Regulatory Manager
Builds
Clinical research studies (Phase I–IV investigational, observational, medical device)
Domain
Life Sciences / Clinical Research
Required skills
IRB/IEC submission management, Trial Master File (TMF) maintenance, essential document collection, regulatory compliance (ICH-GCP, FDA), multi-region study coordination, document tracking and renewal, liaison with sponsors/CROs/sites
Preferred skills
Medical device submission experience, contract and budget negotiation
Technologies
Regulatory tracking systems
Responsibilities
Prepare and execute IRB/IEC submissions (initial, continuing, amendments); Establish and maintain audit-ready TMFs; Collect and track essential regulatory documents; Coordinate translation of study documents; Liaise between sponsors, CROs, sites, and IRBs/ECs; Maintain regulatory tracking systems; Support contract and budget negotiations
Seniority
Mid-level, hands-on IC
