inVentiv Health CRO Monitoring lead (Singapore) in Singapore, Singapore
Title CRO Monitoring lead (Singapore)
Job ID 15765
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
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
Country Singapore [SG]