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ProKidney is a late clinical-stage biotech company focused on the development of a pioneering cell therapy candidate that aims to transform the treatment landscape for Chronic Kidney Disease, with the potential to preserve kidney function and change patients' lives. We are currently growing and looking to add an experienced Sr. Clinical Project Manager who has a minimum of 3 years of CURRENT senior clinical operations experience within a Pharmaceutical company (NOT a CRO), managing all aspects of studies not just overseeing our CRO partners (Vendor Management experience highly desired). Phase III experience REQUIRED. This is a Hybrid position Based out of our BOSTON, MA office. This position requires a solid understanding of clinical drug development, GCP and familiarity with regulatory requirements for the conduct of clinical trials. Strong attention to detail. Excellent written and oral communication skills. Able to effectively use information technology with a proficiency in MS Outlook, Word, Excel and PowerPoint. Exceptional planning and organizational skills. Ability to multi-task and manage cross-functionally and use good judgment when making decisions.
Responsibilities:
We are looking to hire a Sr. Study Manager, Clinical Operations(CSM). This is a unique opportunity to work in a growing Clinical Operations Department that manages late stage clinical programs based on an innovative Regenerative Medicine Advanced Therapy (RMAT) technology platform. The CSM will be responsible for all aspects of clinical trial management aimed at treating moderate to severe diabetic kidney disease. You will be responsible for the successful execution of clinical trials from protocol finalization through closeout.
Qualifications:
Full Time
$97k-127k (estimate)
04/05/2024
07/11/2024
twincitybio.com
Winston Salem, NC
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