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Manager, Global Scientific Affairs

North Wales,Raleigh
Permanent
Reference: JR067705
Description

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them?

At ICON, we have an incredible opportunity for a Manager, Global Scientific Affairs to join the Medical Imaging team in the US.

What you will do:

This person provides scientific oversight for Blinded Independent Central Review (BICR) implementation for clinical trials and acts as in-house expert on imaging endpoints and criteria.

The Role:

  • Recognize, exemplify and adhere to ICON's values, which center around our commitment to People, Clients and Performance.
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Travel (approximately 10%) domestic and/or international.
  • Provides scientific support for Blinded Independent Central Review (BICR) implementation for clinical trials:
    • Reviews and drafts imaging documents to study protocol and SOPs following Sponsor specified timelines:
    • Imaging Charters
    • Site Imaging Manuals
    • Independent Review Training Manuals
    • Image Analysis Platform Configuration
  • Provides scientific support from an imaging perspective for study documents:
    • Study Protocols
    • Response Criteria
    • Case Report Forms
    • Study Reports (Interim and Final)
    • Regulatory Documents
    • Standard Operating Procedures
    • Work Instructions
  • Attends internal team and client team meetings to facilitate medical/scientific project deliverables.
  • Provide appropriate training support to personnel involved in BICR
  • Performs quality control review for other project deliverables as necessary.
  • Regularly communicates project related issues with medical and scientific teams and the project team, as appropriate.
  • UAT of EDC and analysis tools
  • Generate and update policies and procedures for BICR

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