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Clinical Scientist

  • Location: Summit, Union, New Jersey
  • Job Type:Contract

Posted about 1 month ago

  • Expiry Date: 17 September 2021

Job Description:

Must haves:

  • 2+ years of experience working on clinical trials

  • Previous role as a Clinical Scientist, or Clinical Manager/Study Lead

  • Experience with writing study protocols

  • Experience with clinical trial data review and cleaning

  • Advanced Science degree (or additional years of experience if no advanced Science degree)

  • The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.

  • Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct

  • May serve as Clinical Trial Lead for one or more trials

  • May lead or support trial level activities for one or more trials with the necessary supervision

  • May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members

  • Collaborate and liaise with external partners (e.g., KOLs)

  • Seek out and enact best practices with instruction

  • Provide regular and timely updates to manager/management as requested

  • Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required

  • Conduct literature review

  • Submit clinical documents to TMF

  • Develop site and CRA training materials and present these at SIVs and Investigator meetings

  • Review clinical narratives

  • Monitor clinical data for specific trends

  • Develop Data Review Plan in collaboration with Data Management

  • Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming

  • Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)

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ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.