Visit Report Approver

Key responsibilities & duties:

• Effectively review trip reports as per annotated report, protocol, ICON and/or Sponsor SOPs and ensure errors are minimized, reports are consistent across visits and sites and adhere to the highest standards of quality.
• Ensure turnaround time of the trip reports per contract, ICON and or Sponsor SOPs
• Regular oversight of OMR, ICOtrial (and where required Sponsor CTMS and vendor systems) to ensure key metrics, e.g. MVR and FUL timelines, Action Items and other quality metrics are being met and followed-up as necessary
• Ensure open action items and protocol deviations are escalated and followed up for timely resolution as per contract or corporate standards.
• Liaise with CTM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardise the clinical trial delivery or patient safety.

• Track record of successful management of the Clinical Operations aspects of regional/global studies/programs especially extensive experience reviewing trip report.
• Minimum 6 years of monitoring experience.
• Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
• Fluent in written and spoken English. 
• Computer literate.
• Ability and willingness to travel if required
• Team Player