Lead Clinical Trial Manager

Job ID
2017-1116
Category
Clinical Operations
US-MA-Cambridge

Company Summary

As a key member of the Clinical Operations team, you will independently lead a clinical study or studies by overseeing the daily management of clinical trials. The successful candidate will be working closely with the Head of Clinical Operations and will be responsible for completion of study start-up activities in the preparation and implementation of various clinical trials as well as ongoing maintenance through study completion in accordance with the Development Plan.


This position provides an opportunity to join a rapidly growing development organization and contribute substantially to the successful implementation of immunotherapy oncology trials.  In addition, there is an opportunity to expand your knowledge in the science of research as well as immunotherapy in oncology through day-to-day activities and close interactions with the Translational Sciences, Research and Discovery teams within Jounce. 

Role / Responsibilities

  • Develop and drive study timelines and study plans
  • Responsible for vendor oversight (CRO, central lab, specialty vendors, etc)
  • Responsible for managing approved trial budget(s)
  • Develops and oversees study operational plan(s)
  • Interface with the CRO regarding follow-up of status of project activities and deliverables (including but not limited to site identification and selection, pre-trial activities, enrollment, management/conduct, database lock, post-study activities)
  • Proactively identifies project risks and resolves with some supervision, as needed
  • Review and prepare various clinical study documents including but not limited to model informed consent forms, study protocol and amendments, and Investigator Brochure.
  • Maintain and ensure the quality and completeness of study master files across programs in compliance with GCP
  • Represent Clinical Operations in cross-functional initiatives

Qualifications

  • BA/BS; Life Science degree a plus
  • Work experience to include a minimum of 6 years industry clinical trial experience (at least 1 year as a study lead) with a solid understanding of functional area responsibilities associated with the clinical development process
  • Strong working knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
  • Must have strong project management, communication (oral and written), and analytical skills
  • Excellent interpersonal skills, with a demonstrated ability to work in a team environment as well as independently, are required
  • Additional attributes include an ability to multi-task, be flexible, and to thrive in a fast-paced environment
  • Must be able to travel

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

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