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Department: Clinical Development

Job Title: Clinical Trials Manager

Description:

ImmunoGen, Inc. is in search of a motivated Clinical Trials Manager to join our Clinical Development department. The qualified candidate will be responsible for running and closing out our Phase I studies. 
Primary responsibilities include:
  • Ensure the execution of assigned clinical trials in accordance with study protocol, GCP/ICH, regulatory, requirements and Clinical Standard Operating Procedures
  • Plan and run Site Initiation Visits
  • Coordinate and provide oversight to site contracting and budgeting process
  • Develop and manage timelines for assigned clinical trials
  • Ensure CRAs assigned to trial are trained on protocol and relevant SOPs. Review monitoring visit reports, accompany CRAs on site visits as necessary, and initiate/follow up/track significant project issues at investigative sites
  • Review protocols and clinical development documents with regard to feasibility and logistics of implementation
  • Effectively plan, implement, monitor, and provide reports for assigned trials
  • Evaluate and manage CROs as applicable

Job Requirements:

The qualified candidate will possess a RN/BA/BS with a minimum of 5 years experience in clinical research including 3 years of study management. A strong background as a CRA with experience in study monitoring and close out and/or clinical project management is strongly encouraged. Must have a thorough understanding of FDA, ICH and GCP guidelines as well as strong understanding of cross-functional clinical processes. Must possess excellent communication, management and organizational skills. 

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Last updated March 9, 2010