• Clinical Trial Manager

    Job ID
    2018-1164
    Category
    Clinical Operations
    Job Location
    US-MA-Cambridge
  • Company Summary

    Jounce Therapeutics, Inc. is a clinical stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long‑lasting benefits to patients. Through the use of its Translational Science Platform, Jounce first focuses on specific cell types within tumors to prioritize targets, and then identifies related biomarkers designed to match the right therapy to the right patient. Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS and is currently in the Phase 2 portion of the Phase 1/2 ICONIC trial. For more information, please visit www.jouncetx.com.

    Role / Responsibilities

    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).

     

    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

    Technical and Communicative Skills:

    • 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

    Statement

    Jounce Therapeutics is an equal opportunity employer and does not discriminate in it’s employment decisions on the basis of race, color, national origin, age, physical or mental disability, marital status, religion, creed, sex, or political beliefs.  We offer a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the U.S.

     

    To apply, please visit https://careers-jouncetx.icims.com/.

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