Senior Clinical Trial Manager
Remote (USA)
$135,000 - $160,000
Job Description
EPM is partnered with a very exciting clinical stage biotechnology company that is focused on changing the landscape of Neuropsychiatric and CNS disorders. With a drug that is already approved on the market with potential to be a blockbuster, they have ample revenue coming in while still developing 8 new assets. Several of those are in Phase 3 now with a high chance of success, giving you the opportunity to join at a very exciting time. This is a very high potential opportunity with not only room for financial benefits, but tons of room for professional growth and organic vertical mobility. If you want to join a company that has the stability of large pharma, but the opportunity of small biotech, apply now.
Key Qualifications
- A preference for a Bachelor's degree in the field of Life Sciences
- Experience relevant to the role spanning 5-6 years
- Proficiency in GCPs, designing clinical trials, understanding statistics, navigating regulatory procedures, and comprehending global clinical development procedures is required
- Capable of handling multiple tasks concurrently
- Demonstrates flexibility in response to alterations
- Maintains composure when faced with challenging situations
Roles and Responsibilities
- Supervise, execute, and oversee the performance of CRO/Phase 1 Unit and/or third-party vendors to ensure adherences to SOPs and compliance with the defined scope of work within specified timelines and budgets
- Monitor operational study timelines and assess operational performance metrics throughout the study
- Ensuring the CRO(s) provide timely input and produce documents as per protocol and study plans
- Oversee CRO study start up activities and collaborate with various functional groups to guarantee timely collection of essential site documents and initiation of sites according to the study plan
- Holds primary responsibility for the timely, cost-effective, and high quality delivery of operational study objectives, with a global perspective
- Takes independent leadership in crafting the clinical study plan, outlining critical path activities and managing assigned clinical study(s)
- Leads the review and coordination for documents related to the protocol and its amendments
