inVentiv Health CRO Monitoring lead (Singapore) in Singapore, Singapore

Title CRO Monitoring lead (Singapore)

Job ID 15765

Responsibilities

  • Provide CRO Monitoring Oversight for the duties and responsibilities noted below.

  • Review service level agreement to establish specific CPI and KPI metrics in order to evaluate CRO performance for monitoring deliverables

  • Review and provide feedback on CRO performance dashboard

  • Present Monitoring Expectations, providing examples and timelines for deliverables

  • Ensure access is obtained to any CRO systems that will be used during the study (e.g. EDC, CTMS, IWRS)

  • Review CVs for CRAs and proposed CRO staff as needed throughout trial

  • Review and provide feedback on all project plans provided by the CRO including the Project

  • Plan, Communication Plan, Monitoring Plan, CRA Training Plan, Recruitment Plan, Risk Mitigation Plan.

  • Monitor enrollment and verify that monitoring frequency thresholds are met per documented plans; mitigate or escalate non-compliance as needed

  • Review a percentage of monitoring visit reports (Initiation -Closeout) to ensure proper reporting and escalation of events as well as compliance with visit conduct

  • Track visit compliance, report compliance, and report review

  • Monitor SDV and query status, Action Item resolution, protocol deviation/violation for trends and drive compliance with established expectations and scope of work

  • Hold/Attend regular meetings with the CRO to discuss deliverables and overall study management.

  • Verify minutes are posted and tracked

  • Hold and attend regular site Issues meetings with CRO and escalate issues as appropriate

  • Verify CRO's compliance with distribution of IND Safety Letters, as applicable

  • Other duties as assigned.

  • Review and approve site selection documents

  • Review and approve a percentage of sites proposed for Site Selection Visits

  • Review and approve 100% of Sites recommended for Selection into the trial

  • Review and approve agenda and training materials/presentations to be used during CRA Training.

  • Provide input and feedback on Investigator Meeting agenda

Requirements

  • B.A./B.S. (Life Sciences) or related field

  • Six (6) years clinical study site monitoring experience

  • Previous experience as a Regional Lead CRA preferred

  • Ability to travel at least 30% of time

City Singapore

Country Singapore [SG]