Manager, Clinical Compliance & Records

THE OPPORTUNITY

The Manager, Clinical Compliance & Records will work closely and collaboratively with clinical 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 Associate Director, Trial Master File, this key role will assist with inspection readiness activities, contribute to ongoing compliance efforts, and help implement process improvement strategies by collaborating with internal teams and external stakeholders.

THE 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.

REQUIRED QUALIFICATIONS

• 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.

PREFERRED REQUIREMENTS

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

WORK LOCATION AND CONDITIONS

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Delaware, Hawaii and Kansas.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested.
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.