Associate Director, Clinical Compliance & Records
Amylyx Pharmaceuticals
July 01, 2026
Remote
United States
Operations
Responsibilities
- Provide Study Management Teams (SMTs) guidance on ICH-GCP, FDA guidelines, and applicable regulatory requirements across the clinical trial lifecycle.
- Identify, assess, trend, and manage study-related risks/issues; lead/support investigations, CAPA, and continuous process improvement; escalate significant quality/compliance risks.
- Support Quality Event (QE) management (Oversight Registers, risk/impact assessments, RACT updates, sponsor oversight documentation such as storyboards and evidence packages).
- Create and maintain study-specific training matrices; ensure SMT training on required study documents.
- Collaborate with Quality Assurance and Clinical Operations to ensure SOPs/forms/templates meet organizational needs; manage periodic review schedules for SOPs and study plan adherence evaluations.
- Facilitate inspection readiness and internal audits; track and follow up on inspection/audit actions.
- Support/back up the Director with leadership and guidance for the Clinical Compliance team.
- Lead Clinical Records strategy: eTMF processes, procedural documents, TMF Plans/indexes, migrations, change controls, deviations, CAPA; oversee TMF setup/maintenance/archival.
- Oversee eTMF access and user permissions; act as TMF SME; monitor TMF health/metrics; support Veeva Clinical training.
- Identify and implement TMF process improvements; lead Veeva Clinical TMF content migrations if needed.
Required Qualifications
- Bachelor’s in health/science + 8+ years pharma/biotech experience in Clinical Compliance and/or TMF.
- Experience applying ICH/GCP and FDA guidelines; strong TMF Standard (TMF Reference Model) knowledge; Veeva Clinical/Veeva Quality preferred.
- MS Office (Word, Excel, SharePoint, PowerPoint); strong collaboration, organization, time management, and oral/written communication; comfortable working in a fast-paced small company.
Preferred Qualifications
- Experience with US FDA/EMA/MHRA or other inspections.
- Experience as Business Administrator for electronic Trial Master File systems.
Compensation
- Estimated pay range: $171,000–$192,000 USD.
Application Instructions
- Apply through the company website (link provided in posting).
- Provide Study Management Teams (SMTs) guidance on ICH-GCP, FDA guidelines, and applicable regulatory requirements across the clinical trial lifecycle.
- Identify, assess, trend, and manage study-related risks/issues; lead/support investigations, CAPA, and continuous process improvement; escalate significant quality/compliance risks.
- Support Quality Event (QE) management (Oversight Registers, risk/impact assessments, RACT updates, sponsor oversight documentation such as storyboards and evidence packages).
- Create and maintain study-specific training matrices; ensure SMT training on required study documents.
- Collaborate with Quality Assurance and Clinical Operations to ensure SOPs/forms/templates meet organizational needs; manage periodic review schedules for SOPs and study plan adherence evaluations.
- Facilitate inspection readiness and internal audits; track and follow up on inspection/audit actions.
- Support/back up the Director with leadership and guidance for the Clinical Compliance team.
- Lead Clinical Records strategy: eTMF processes, procedural documents, TMF Plans/indexes, migrations, change controls, deviations, CAPA; oversee TMF setup/maintenance/archival.
- Oversee eTMF access and user permissions; act as TMF SME; monitor TMF health/metrics; support Veeva Clinical training.
- Identify and implement TMF process improvements; lead Veeva Clinical TMF content migrations if needed.
Required Qualifications
- Bachelor’s in health/science + 8+ years pharma/biotech experience in Clinical Compliance and/or TMF.
- Experience applying ICH/GCP and FDA guidelines; strong TMF Standard (TMF Reference Model) knowledge; Veeva Clinical/Veeva Quality preferred.
- MS Office (Word, Excel, SharePoint, PowerPoint); strong collaboration, organization, time management, and oral/written communication; comfortable working in a fast-paced small company.
Preferred Qualifications
- Experience with US FDA/EMA/MHRA or other inspections.
- Experience as Business Administrator for electronic Trial Master File systems.
Compensation
- Estimated pay range: $171,000–$192,000 USD.
Application Instructions
- Apply through the company website (link provided in posting).