Manager, Clinical Compliance & Records

Summary

Join Amylyx Pharmaceuticals as their Manager, Clinical Compliance & Records! This key role ensures compliance with SOPs, ICH/GCP, and regulations in clinical studies. Collaborate with clinical Study Management Teams (SMTs) to provide guidance, manage risks, and implement process improvements. Assist in inspection readiness, maintain team rosters and training matrices, and manage periodic reviews of SOPs and forms. Support the management of clinical records within the eTMF and identify/escalate compliance risks. This remote-friendly position requires US residency and occasional travel to Cambridge, MA.

Requirements

• Bachelor’s Degree in a health related or scientific discipline with 5+ years of pharmaceutical or biotechnology industry experience, working in a quality assurance or clinical compliance position supporting Clinical Operations
• Experience with the interpretation and application of ICH/GCP expectations and standards to varying phases of clinical studies
• Working knowledge of Veeva Quality and Veeva Clinical Vault 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
• 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
• 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

Responsibilities

• Support Amylyx clinical Study Management Teams (SMTs) by providing guidance on ICH/GCP compliance and staying current on applicable regulations and Amylyx standard operating procedures (SOPs)
• Apply ICH/GCP guidance and clinical compliance knowledge across various stages of clinical research, including participation in trend analysis for identification and management of study-related risks and issues. Work with SMTs to ensure the creation of storyboards and/or other supporting documentation
• Partner with SMTs and Functional Leads to create and maintain robust team rosters and study-specific training matrices. Help ensure the timely completion of training per study-specific training matrices
• Assist Clinical Compliance & Records and Clinical Operations leadership in managing 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
• Assist Clinical Compliance & Records and clinical study leadership to ensure SOPs and procedures used to conduct and oversee clinical studies are documented in study-specific plans
• Support inspection readiness activities in Clinical Operations by assisting with preparation for, participation in, and following Regulatory inspections and internal audits. This may include tracking of follow up actions resulting from inspections and audits
• Provide support with activities related to the management of clinical records within the electronic Trial Master File (eTMF), as needed
• Identify and escalate significant quality and compliance risks to departmental leadership. Participate in investigation and mitigation measures

Preferred Qualifications

Experience in rare diseases, or neurologic or metabolic conditions is highly desirable