Clinical Scientist

Summit, New Jersey
Industry: Scientists / Research / Lab Technician
Job Number: JN -072021-67094

Responsibilities will include:

  • Assist the Clinical Research Scientist team to interface with project team members including Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
  • Review and query of haematology/oncology data including safety, primary efficacy variables, and laboratory data.
  • Assist with protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
  • Assist with Study Start up Activities and data base build.
  • Participate or lead in Scientific meetings (i.e. Ad-Board, Steering Committee, Data Monitoring Committee)
  • Potentially assume study lead responsibilities, manage study, work independently
  • multi-tasking, i.e. working on multiple studies and/or multiple deliverables.

Skills/Knowledge Required:

  • Minimum 6 yrs. experience in oncology/haematology clinical development
  • Excellent written and verbal communication skills and interpersonal skills.
  • Knowledge of clinical trial design, basic statistics, and data review tools
  • Proficient at data interpretation
  • Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
  • Full understanding GCP and ICH Guidelines
  • Detail-oriented, well-organized
  • Ability to assimilate technical and scientific information quickly.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus), JReview, EDC (Rave)
  • Demonstrated ability to work as part of a team.
  • Haematology experience (plus). Protocol authoring (preferred).
  • Data review and medical monitoring of data (required).
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