Senior Clinical Project Manager Position Available In Suffolk, Massachusetts
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Job Description
Seeking a Senior Clinical Project Manager for our client – a clinical stage biotechnology company focusing on a potent and unique therapy to treat cancer.
Type :
Direct Hire Location :
Remote Responsibilities:
Oversee study activities, including reviewing monitoring reports and conducting TMF (Trial Master File) checks. Attend status meetings, taking and reviewing meeting minutes as needed. Validate service completion through detailed invoice reviews. Assist the CRO in resolving site-level issues, including instances of non-compliance. Track data cleaning metrics and address any identified backlogs. Develop, review, or update essential study documents, such as ICFs, protocols, study plans, and training materials. Deliver regular updates on progress and milestones. Ensure the study remains on track with the approved budget and timelines.
Qualifications:
Bachelor’s degree in life sciences, physical sciences, or nursing. 10-12 years of professional experience, including at least 3 years as a Clinical Trial Manager (CTM) or Clinical Trial Project Manager. Previous experience collaborating with a Contract Research Organization (CRO). Proficiency in ICH GCP guidelines, U.S. regulations, project management, clinical operations, study budgets, and timeline management. Familiarity with Medidata RAVE, clinical trial management systems, and Excel.
