GCP Consultant

Newton , MA | Contract

Post Date: 06/28/2018 Job ID: 226708 Industry: Life Sciences
GCP Consultant
• Senior GCP Consultant with expertise in BIMO inspection readiness is needed for a 3-6 Month Contract in Newton, MA
• The qualified individual will need to be experienced in developing Story Boards with SMEs to cover ClinOps (safety review/closing gaps), Monitoring, Safety/PV. This will also involves coaching SMEs in preparation of the inspection. 
Required Skills:
• 10+ years’ experience in Clinical Trial Management/oversight.
• GCP Oversight is a must
• BIMO inspection readiness is a must
• Inspection interview/interrogation tactics experience, storyboard preparation expertise (working with cross-functional groups to help develop and shepherd their storyboards to excellence).
• Fluid thinker/flexible based on changing priorities
Desired Skills:
• Oncology experience
• Medical Research eperience
• Bachelor's Degree
Duration: 3-6 Months

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