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Senior Clinical Trial Manager

New Jersey All, NJ

Post Date: 04/09/2018 Job ID: JN -042018-21290 Job Type: Clinical
  • Responsible for the overall operational planningand activities for the implementation and conduct of studies (R&D clinical trials or Medical Affairs clinical trials, observational studies, compassionate use and registries) including oversight of data management activities in compliance with GCPs, SOPs and standards within established timelines and budgets
  • Involved in the scientific conduct of the study and acts as the leader of operational disciplines to create, implement and manage an operational trial plan including risk management plan to secure clinical trial deliverables on time, within budget and with quality, in close collaboration with others Clinical Trial Team department representatives
  • Provides input into identifying implications of study progress on overall timeline goals and conduct plans
  • Provides input into content and execution of investigator meetings and may present selected topics
  • With oversight, develops informed consent form and coordinates input
  • With oversight, provides point of contact for site questions relating to study conduct issues
  • Participates in the implementation of key organizational process improvement initiatives
  • Responsible for serving as clinical trial leader for large-scale multi-country trials
  • Responsible for protocol preparation, generation of manuals for trial support committees and other trial documentation
  • Lead the multi-disciplinary team responsible for study completion
  • Writes and reviews abstracts/manuscripts, etc. for presentation/publication at internal/external meetings
  • Experience managing Investigator Sponsored Trials
  • Bachelor's Degree is required

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