Clinical Trial Medical Monitor

Published: August 7, 2017

Description

Requisition No.: 21551-1

Status: Full Time

Project Duration: 6 months

Position Description:

  • Attend weekly update meeting with core team (PM, DM, stats)
  • Attend weekly meetings with CRO and/or other vendors
  • Help CRO respond to site and HA questions about the protocol
  • Monthly review of Jreview and CRO data listings and QNET lab data. Attend monthly safety meetings with CRO
  • Review daily lab alerts and SAEs. Communicate with CRO regarding follow-up.
  • Monthly review of protocol deviations
  • Attend and present at Investigator meetings
  • CRF review
  • Present study updates at CPT
  • Monthly participation in MST
  • DBL (final listing review, review of blinded TLF, review protocol deviations, participate in all DBL meetings)
  • CSR writing (review final TLFs, work with medical writer to review & revise CSR document, draft discussion and conclusions, participate in comment resolution meetings)
  • Topline results presentation
  • Other tasks may be required as determined during the project

Skills Required

• Excellent written and verbal communication skills are required
• Strong interpersonal skills including the ability to influence others
• Strong leadership skills

Experience Required

• MD or DO with experience in diabetes or at a minimum in internal medicine
• A minimum of 10 years of industry experience
• In depth knowledge of and experience as a medical monitor for clinical trials
• Good verbal and written communication skills essential
• Experience managing projects in a matrix environment, coordinating activities and adhering to tight timelines
Apply
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