Clinical Trial Manager

Job ID
2018-1128
Category
Clinical Operations
Job Location
US-MA-Cambridge

Company Summary

The Clinical Trial Manager (CTM) will work collaboratively with the Lead Clinical Trial Manager to drive ongoing clinical studies.  The CTM will also independently organize and manage multiple activities related to clinical studies, while simultaneously ensuring study milestones are met and studies are completed in accordance with the protocol.  Future growth opportunities would include independently managing  small studies of basic to moderate complexity or defined activities in more complex, multicenter studies (e.g., managing vendors).

Role / Responsibilities

  • Directly oversees selected vendor (s) to ensure compliance with the contract specifications and applicable SOPs
  • Ensures accurate, timely, and complete tracking of laboratory samples
  • Applies thorough knowledge of GCP/regulatory requirements to all aspects of the study
  • Prepares all external and internal documentation for assigned trials ensuring it is completed in accordance with the study protocol, internal SOP’s and GCP requirements (e.g., Patient Informed Consent Forms, Monitoring Plans, Project Plans)
  • Works with the Lead CTM to develop and maintain study timelines
  • Oversees clinical site monitoring activities and co-monitors as needed
  • Conducts training regarding the operational aspects of the clinical trial including protocol, lab manuals, etc. to both internal team members and clinical site staff
  • Provide period quality control of the Trial Master File
  • May represent Clinical Operations in cross-functional initiatives
  • Performs other duties as assigned

Qualifications

  • Displays project management skills to projects and/or activities with assistance from Senior Clin Ops staff
  • Demonstrates ability to communicate and coordinate activities with the internal team, clinical sites and vendors
  • Able to proactively identify project challenges/risks and implement appropriate actions with some supervision
  • Effectively organizes cross functional team (primarily internal to Jounce)
  • Strong communication (written and verbal) skills
  • Demonstrated computer skills; proven functional knowledge of Microsoft packages and ability to develop proficiency in relevant Jounce systems and programs

PREFERRED EDUCATION AND EXPERIENCE:

B.S. (or equivalent experience) and 3 – 6 years of relevant work experience

M.S. (or equivalent experience) and 2 – 4 years of relevant work experience

 

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