Associate Director, Clinical Compliance & Records
Remote / Online - Candidates ideally in
Phoenix, Maricopa County, Arizona, 85003, USA
Listed on 2026-10-09
Phoenix, Maricopa County, Arizona, 85003, USA
Listing for:
Scorpion Therapeutics
Remote/Work from Home
position Listed on 2026-10-09
Job specializations:
-
Healthcare
Healthcare Compliance, Medical Science, Clinical Research
Job Description & How to Apply Below
Associate Director, Clinical Compliance & Records, overseeing clinical trial compliance and TMF management for Amylyx's post-approval and early-phase studies in rare neurological and metabolic diseases.
Responsibilities- Ensure adherence to ICH-GCP, FDA, and SOPs; lead risk assessments, CAPAs, inspection readiness, and audit support; develop and maintain TMF strategies, including eTMF processes, documentation quality, and system migrations; collaborate with Clinical Operations, Quality, and Study Teams to drive process improvements.
- Bachelor's in a health or science field; 8+ years in clinical compliance or TMF roles within pharma/biotech; strong knowledge of ICH-GCP, FDA guidelines, and TMF standards; proficiency with Veeva systems and MS Office.
- Experience supporting FDA/EMA inspections, TMF system administration.
- High Value: focus on clinical compliance and TMF in early to late-phase studies, including post-market activities; experience with Veeva Clinical; working knowledge of inspection readiness; remote work within the U.S. with periodic travel to Cambridge, MA.
Position Requirements
10+ Years
work experience
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