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Senior Clinical Project Manager/Clinical Scientist

New Jersey All, NJ

Post Date: 05/11/2018 Job ID: JN -052018-21568 Job Type: Clinical
  • Responsible for all operational aspects of 1 or more OGD clinical trial(s) under the leadership of Clinical Trial Head (CTH)
  • Support all scientific aspects of clinical trial(s) as assigned
  • Responsible for program level activities as assigned
  • Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards
  • Provide input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing
  • Prepare training materials and presentations related to the planning and conduct of the trial
  • Prepare clinical outsourcing specifications
  • Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget
  • Manage interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and local medical organizations
  • Accountable for accuracy of trial information in all trial databases and tracking systems
  • Support the development, management and tracking of trial budget working closely with the appropriate partners in OGD
  • Participate in the organization and logistics of various oversight and Advisory boards; attend meetings
  • Point of contact for managing/answering questions related to trial procedures and patients' eligibility
  • Write CTT meeting minutes
  • May occasionally deputize for the CTH at Clinical Trial Team meetings
  • May participate in International Clinical Team meetings
  • Contribute to program level activities (e.g., tracking of OGD program-related publications, development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions)
  • Demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and publishing activities

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