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Trip Report Reviewer

014562_2

About the role

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SECTION 1: POSITION SUMMARY
� To effectively review trip reports as per Protocol and ICON and Sponsor SOPs and to ensure the
quality of reports are of the highest standards, errors are minimized and that issues are escalated as
Appropriate
� To follow up on action items and protocol deviations and to be a liaison between CRA, CTM and PM
for timely resolution of issues.
� To act as an extension of the CTM/CTM team for the specific purpose of trip report review.
� To observe and escalate safety trends in patients as identified in trip reports
SECTION 2: JOB FUNCTIONS/RESPONSIBILITIES
(List statements in bullet format. Put an asterisk* next to each essential function. The definition of an essential
function is included in the Job Description Form Guidelines within iDoc)
� *Recognize, exemplify and adhere to ICON's values which centers around our commitment to People,
Clients and Performance.
� *As a Manager, the employee is expected to recognize the importance of and create a culture of
process improvement with a focus on streamlining our processes adding value to our business and
meeting client needs.
� *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.
� Where required, attend project meetings and actively provide suggestions for improvement of quality
of reports, provide feedback for timely and appropriate resolution of action items and report trends
� *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.
� *Ensure all necessary trainings, required to improve job performance and knowledge, are completed
in a timely manner
� Contribute towards quality improvement and risk management plans to minimize impact on project
objectives and deliverables, and patient safety and show consistent improvement in metrics
� Actively support staff with change management
� Liaise with other managers to improve the effectiveness of the organization
� Other duties as assigned
� Travel (approximately 0%) domestic and/or international
SUPERVISION
(List statements in bullet format. Put an asterisk* next to each essential function.)

� Supervision of staff is not expected

List #1

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