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Associate Director, Clinical Operations
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Full-time
- Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.
- The AD, Clinical Operations is responsible for managing all aspects of multiple clinical trials with emphasis on CRO, vendor and internal team management to drive a high functioning and results- driven team including timeline adherence, patient safety, adherence to contracted deliverables, the protocol(s), appropriate regulations, and data integrity.
- Oversee CRO and/or vendor activities and coordinate cross-functional department activities to successfully achieve milestones and quality deliverables in study management, including but not limited to site selection, study start-up, recruitment, study conduct, and database lock and study close-out
- Contribute to development of plans and documents led by other functions such as data management and data review plans, statistical analysis plan, safety management plan, etc
- Lead quality reviews of study conduct, including TMF and monitoring report reviews, and lead inspection readiness activities for both internal sponsor audits and health agency audits (FDA, Health Canada, etc)
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