As a key member of the Clinical Operations team, this successful candidate will work closely with the Vice President of Clinical Operations and will be responsible for leading the activities in the preparation, implementation, and completion of various clinical trials in accordance with the Development Plan.
This position also provides an opportunity to join a growing development organization and contribute substantially to how the company will operationalize novel immunotherapy oncology trials in the future. In addition, there is an opportunity to expand your knowledge in the scientific and research aspects of immunotherapy in oncology through day-to-day activities and close interactions with the Translational Sciences, Research and Discovery teams within Jounce.
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 – work closely with discovery, translational and pre-clinical research colleagues.
Manage other Clinical Operations staff
Qualifications
Requirements
BA/BS; Life Science degree a plus
Work experience to include a minimum of 10 years’ industry clinical trial experience (at least 5 years as a study lead) with a solid understanding of functional area responsibilities associated with the clinical development process
Minimum 2 years of direct supervisory experience
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 15%
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