Location: 
Bedford
Employment Type: 
Contract
Job ID: 
133721
Description: 

The Clinical Project Manager is responsible for the design, execution, and results of clinical studies.  This includes building the project plan, developing the protocol, initiating and executing the clinical study, and working with Regulatory to use study results for product approvals.  Studies must be conducted meeting enrollment timelines and budgets.  The position ensures all studies are conducted in compliance with GCP and all applicable standards and regulations.

·         Provide operational leadership and accountability to meet corporate clinical goals, including execution of clinical studies in accordance with the protocol; meeting study timelines and budgets

·         Ensure the design and conduct of the clinical studies is done in full compliance with GCP and regulatory standards

·         Develop clinical protocols  

·         Prepare and present study project plan including timelines and budgets

·         Identify potential vendors for the clinical trial execution, including CROs, Monitors, EDC data management systems, Imaging Core Labs, and Biostatisticians.  Qualify and select vendors

·         Direct site selection and qualification processes

·         Negotiate site, investigator, and vendor contracts and budgets in collaboration with Finance & Legal Departments

·         Provide operational oversight during trial period; complete site visits, report review, report preparation, payments to sites, compilation and completion of Trial Master File

·         Ensure study is conducted in full compliance to GCP and regulatory requirements

·         Monitor vendor activity to ensure study is being conducted according to protocol, timelines and budget

 

·         Bachelor’s degree in the life sciences or health care field

·         2 - 5 years in direct clinical project management experience within the biopharmaceutical or medical device industry

·         Demonstrated experience as a Project Manager on multi-center, FDA regulated IDE and/or IND studies

 

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