Manager, Clinical Compliance & Records

Amylyx Pharmaceuticals; Cambridge (MA); Remote; USD 80,000 - 110,000; Full time

Job summary

An innovative clinical-stage pharmaceutical company seeks a Manager for Clinical Compliance & Records. This role is vital in ensuring clinical studies adhere to rigorous standards and regulations. You will collaborate with Study Management Teams to enhance compliance efforts and improve processes, making a significant impact on the company's mission to develop therapies for unmet medical needs. In a fast-paced environment, your expertise will guide teams in maintaining quality and compliance, ultimately benefiting the communities we serve. Join a passionate team dedicated to making a difference in patients' lives.

Qualifications

• 5+ years in pharmaceutical or biotech quality assurance or clinical compliance.
• Knowledge of ICH/GCP standards for clinical studies.

Responsibilities

• Support clinical Study Management Teams on compliance with SOPs and regulations.
• Assist in inspection readiness and manage clinical records.

Skills

ICH/GCP Compliance

Quality Assurance

Clinical Compliance

Interpersonal Skills

Organizational Skills

Communication Skills

Education

Bachelor's Degree in Health or Scientific Discipline

Tools

Veeva Quality

Veeva Clinical Vault

MS Office (Word, Excel, SharePoint, PowerPoint)

Job description

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve.

Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - create a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and determination, we encourage you to read the opportunity below and apply.

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 / Director, Clinical Compliance & Records, 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

• 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.

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Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.