Recognize, exemplify and adhere to ICON's values which center on Integrity, Inclusion, Agility and Collaboration:
May include the following in collaboration with PM and cross functional leads, depending on study/ partnership assignments:
During set-up study award to FPR + 3 months
- Authoring of RBQM plan
- Identification and documentation of CtQ
- Identification and documentation of critical data and processes
- Facilitation of the initial risk assessment process and meetings
- Ensuring on time and high-quality risk assessment completion
- Review critical data path /data flow in association with Clinical data science lead
- Review of critical data review methods in association with Clinical data risk analyst who is the author and owner of DRP.
- Input and review of Risk based monitoring strategy- T-SDV/T-SDR, reduced SDV/SDR in collaboration with CTM
- Review/input into QTLs
- Review/input into central monitoring Key risk indicators
- Quality Gate - Review/input into all applicable Fucntional plans to ensure risk mitigations are appropriately covered.
- Initiate ongoing risk reviews
- Initiate QRRM
During Maintenance
Quarterly- Operational Quality review checks to ensure:
Proactive identification, resolution/mitigation, and escalation of study level risks and/or issues- QRRM output
Monitoring strategy is operationalized as per plan and in alignment with budget
Periodic Risk assessments as required by changes to critical data or risks or change in milestone or protocol amendments
Input into division or program-level oversight, quality and compliance processes related to RBQM requirements.
study level reviews of quality related data, to identify trends and potential risks, including:
- Project non-conformance trending
- CAPA trending (project and site level CAPAs)
- Critical and Major audit & inspection findings (study and site level)
- Present review output to PM and FTLs, collaborating with them on the identification of risks, proposing potential risk mitigations and actions
- Report to Governance and oversight dashboard as per plan
- Serves as a point of escalation