Clinical Operations Manager

2 weeks ago


Cambridge, Massachusetts, United States Lifelancer Full time
About the Role

We are seeking a seasoned Clinical Operations Manager to join our team at Amylyx Pharmaceuticals. In this role, you will be responsible for managing clinical studies in Post-Bariatric Hypoglycemia (PBH), ALS, PSP, Wolfram Syndrome, and other diseases under study.

Responsibilities
  • Directly manage clinical trials from start-up through close-out, ensuring effective planning, execution, risk management, data integrity, quality, and compliance with Company SOPs, ICH-GCP guidelines, GDPR, and other regulations and patient safety standards.
  • Develop, analyze, and report on metrics for clinical programs.
  • Collaborate with Clinical Leadership to ensure study deliverables are achieved on time and within budget.
Requirements
  • BS/BA Degree, in science or a health-related field preferred.
  • Minimum 8 years of clinical operations experience in a pharmaceutical/biotech, and/or CRO setting.
  • Experience and understanding of global clinical trial operations; study startup through close-out; strong vendor management skills; inspection-ready mind-set.
  • Exceptional knowledge of GCP, ICH, and FDA regulations.
  • Must be able to travel up to 20% domestically and internationally.
Benefits
  • 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.
  • 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.

The estimated salary for this position is $120,000-$180,000 per year, depending on experience.



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