Job Description
One of our large Life Sciences clients is looking for a Senior Clinical Trial Leader to help support a medical device cardiovascular clinical trial . This individual will manage day-to-day operations of said clinical trials, including budgets and oversight of Clinical Research Associates (CRAs) and other operational team members. They will collaborate with cross-functional partners to ensure smooth execution of trials and oversee Trial Master Files (TMFs), payments, and ensure all documentation is cleaned up and organized. They will ensure adherence to IDE regulations, focusing on patient safety and regulatory compliance and prepare comprehensive reports and updates for stakeholders.
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Required Skills & Experience
-BS Degree or higher in life sciences related field
-3-5 years experience as a Clinical Trial Leader/PM
- IDE/Pre-Market Clinical Trial experience
- 2+ years experience with Medical Device Clinical Trials (Biosurgery/Wound Closure)
-Independently running trials
Nice to Have Skills & Experience
-Global regulatory experience (UK, EU)
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.