Clinical Operations Manager
2 weeks ago
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.
- 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.
- 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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Clinical Operations Manager
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Senior Clinical Operations Manager
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Clinical Operations Manager
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Clinical Operations Manager
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Cambridge, Massachusetts, United States Lifelancer Full timeCompany Overview: Amylyx Pharmaceuticals is a pharmaceutical company based in Cambridge, Massachusetts, dedicated to the discovery and development of potential treatments for diseases including Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS).About the Role: We are seeking an experienced Senior Clinical...
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