Associate Director, Clinical Compliance & Records

📋 Description

• Ensure trials comply with SOPs, ICH/GCP, and applicable regs.
• Lead TMF strategy and inspection readiness with SMTs.
• Manage QA, CAPA, risk assessments, and issue escalation.
• Maintain sponsor oversight docs, risk tools, and evidence packages.
• Develop and maintain study-specific training matrices.
• Align SOPs, forms, and templates with evolving needs.

🎯 Requirements

• Bachelor's Degree in health/science with 8+ years in Clinical Compliance/TMF.
• Deep experience applying ICH-GCP and FDA guidelines to clinical studies.
• Strong TMF knowledge; Veeva Clinical workflows preferred.
• Proficiency with MS Office (Word, Excel, SharePoint, PowerPoint).
• Excellent communication, organization, and cross-functional collaboration.
• Thrive in a fast-paced, small-company environment; able to start quickly.
• Preferred: FDA/EMA/MHRA inspections experience and eTMF system administration.

🎁 Benefits

• Remote-friendly role with US residency requirement.
• Travel to Cambridge, MA several times per year.
• Equal opportunity employer with accommodations available.