Clinical Research

• Act as Delegate when assigned on a study.
• Authoring of Quality & Risk Management Plan
• Facilitate - Identification and documentation of CtQ
• Facilitate - 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 Data Review Requirements.
• 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 Functional plans to ensure risk mitigations are appropriately covered.
• Initiate ongoing risk reviews
• Initiate Risk Review Meetings - QRRM
• Quarterly- Operational Quality review checks to ensure- Ø Ongoing Risk Review and ensure Risk & Risk control review are documented Ø Risk Review Meetings are conducted as planned- with proactive and fully engaged functional leads and sponsor when applicable.
• Review QRRM slides to identify the adequacy of content in RRM slides.
• Ø Monitoring strategy is operationalized as per plan and in alignment with budget
• Periodic Project 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.
• Ø 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 for RBQM and/or quality issues for the project team

Senior Clinical Trial Manager

Principal Biostatistician