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Clinical Scientist

New Jersey All, NJ

Posted: 09/30/2018 Job Type: Clinical Job Number: JN -092018-22691
  • Review of clinical data within eCRF system, patient profiles, etc. to issue queries and clean data from clinical perspective
  • Conduct review of ongoing summary data including: safety, primary efficacy variables, and laboratory data
  • Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management
  • Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc.
  • Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate)
  • Clinical study report preparation
  • Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.
  • Participate and/or lead team meetings as required
Skills/Knowledge Required
  • Degree in life sciences
  • Clinical/Medical background and experience working as a Clinical Research Scientist
  • Candidate must have experience working on clinical trials as a Clinical Research Scientist from a sponsor's perspective
  • Must have at least two years of direct hematology/oncology experience
  • Must have experience performing data review in hematology/oncology indications
  • Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data
  • Ability to function independently in data review to identify discrepancies in clinical trial data and to write queries from a medical perspective
  • Familiarity with Medidata, RAVE, J-review or other clinical databases or other data review tools (patient profiles, listings)
  • Some experience in medical writing such as authoring or co-authoring documents such as protocol, clinical study report, investigators brochure, patient narrative, etc.
  • Ability to communicate medical or clinical information to a physician

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