The Opportunity

The Associate Director, Clinical Compliance & Records will work closely and collaboratively with Clinical Operations leadership and Study Management Teams (SMTs) to ensure that Amylyx clinical studies are conducted in compliance with Standard Operating Procedures (SOPs), ICH/GCP, and other applicable regulations. Reporting to the Director, Clinical Compliance & Records, this role will participate in SMTs, providing leadership for TMF strategy and process, and partnering with internal and external stakeholders on inspection readiness initiatives, supporting management of overall compliance and identifying and implementing process improvement strategies. 

Responsibilities: Clinical Compliance

• Provide Study Management Teams (SMTs) with guidance on the application of ICH-GCP standards, FDA guidelines, and other applicable regulatory requirements throughout the clinical trial lifecycle.
• Apply clinical compliance knowledge to identify, assess, trend, and manage study-related risks and issues. Lead or support investigations, CAPA activities, and continuous process improvement initiatives. Escalate significant quality and compliance risks to departmental leadership. 
• Partner with Clinical Operations and cross-functional SMT members to support Quality Event (QE) management, including maintaining Oversight Registers, facilitating risk and impact assessments, updating Risk Assessment Categorization Tools (RACTs), and ensuring the development and maintenance of sponsor oversight documentation, such as storyboards and supporting evidence packages.
• Partner with SMTs and other members of the Clinical Compliance and Records team to create and maintain study-specific training matrices. Ensure SMT members are trained on appropriate study documents per study-specific training matrices.
• Collaborate with Quality Assurance and Clinical Operations to ensure that Clinical Operations written standard operating procedures, forms, and templates meet the changing needs of the organization.
• Create and manage a periodic review schedule, to ensure that Clinical Operations written SOPs, forms, and templates are assessed in a timely fashion and in conjunction with defined procedures.
• Create and manage periodic review schedules for study plans and evaluations of adherence to defined processes.
• Facilitate and support inspection readiness activities by collaborating with Clinical Operations, SMTs, and Clinical Quality to ensure appropriate preparation for, participation in, and follow-up from Regulatory inspections and internal audits. This may include tracking of follow up actions resulting from inspections and audits.
• Serve as support for and back-up to Director, Clinical Compliance and Records, providing guidance and leadership for the Clinical Compliance team and operations, ensuring alignment with departmental goals and organizational priorities.

Responsibilities: Clinical Records

• Provide leadership for Clinical Records strategy, including management of electronic Trial Master File (eTMF) processes, procedural documents (e.g., SOPs, Work Instructions, User Guides), TMF Plans and associated indexes, TMF migrations, change controls, deviations and CAPAs.  
• Establish, follow, and oversee processes for TMF set up, maintenance, and archival across Amylyx clinical studies.  
• Oversee and facilitate the eTMF access process. Ensure appropriate internal and external user permissions by monitoring, granting, modifying, and revoking access as needed.
• Serve as TMF Subject Matter Expert, supporting cross-functional departments to ensure high quality documentation and appropriate TMF structure. Collaborate with internal and external stakeholders to resolve TMF quality issues.
• Monitor TMF health and provide study-specific metrics according to the TMF Plan.
• Participate in the development and delivery of Veeva Clinical (eTMF) training for internal and external users.
• Support audit and inspection readiness activities, including TMF preparation.
• Identify and implement process improvements in collaboration with key stakeholders to aid with the improvement of TMF efficiency, usability, and compliance.
• Lead migrations of TMF content to Veeva Clinical (eTMF), if needed, working with Director, Clinical Compliance and Records to define resourcing and efforts required to complete TMF migrations.  
• Ensure TMF content and metadata meet departmental standards, good documentation practices, and Good Clinical Practice (GCP) requirements.
• Serve as support for and back-up to the Director of Clinical Compliance and Records, providing guidance and leadership for the TMF operations team and/or other clinical roles involved in TMF activities, ensuring alignment with departmental goals and organizational priorities.

Required Qualifications

• Bachelor’s Degree in a health related or scientific discipline with 8+ years of pharmaceutical or biotechnology industry experience, working in Clinical Compliance and/or TMF focused roles.  
• Experience with the interpretation and application of ICH/GCP standards and FDA guidelines to varying phases of clinical studies.
• High level of competency with TMF Standard (i.e., TMF Reference Model), and working knowledge of Veeva Clinical and Veeva Quality workflows preferred.
• Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint.
• Excellent interpersonal and professional skills and ability to work collaboratively across functional teams.
• Strong organizational and time management skills.
• Excellent communication skills, both oral and written.
• Must have the enthusiasm to work at a small company and work in a fast-paced environment and be ready to dive right in once hired.
• Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint. 

Preferred Requirements

• Prior experience supporting and/or participating in US FDA, EMA, MHRA or other health authority inspections 
• Prior experience as a Business Administrator over electronic Trial Master File systems.

Work Location and Conditions

• This is a remote friendly role, but you must reside and work within the United States, and in a state where Amylyx currently does business, to be considered. Any change in your remote location must be approved by Amylyx
• You will be required to follow Amylyx’s Remote Work Policy which includes:  
  • traveling to our corporate location in Cambridge, MA several times a year and attending other company-related events as necessary and requested, which may include travel by air, driving, or public transportation.
  • working in a setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote location
  • Information security protocols and steps to maintain confidentiality of Amylyx information, technology, and materials