Clinical Risk Manager

Overview:

The Clinical Risk Manager will coordinate and oversee the execution of risk management for GCPM managed studies, (early, late and observational), globally oversee the quality of risk management for studies at a global level. The Risk Manager collaborates with cross functional stakeholders to ensure continuous, timely and quality risk management.

Responsibilities:

• Leading the Clinical Study Team to drive effective decision making for risk management
• Ensuring risk management implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
• Responsible for CT-RACT completion and updates (by the CST) throughout the lifecycle of the clinical study
• Input to the development of the study protocol and functional plans
• Plan and lead high quality risk management discussions and reviews, including the identification and review of risks, critical data & critical processes
• Guide team on the process, requirements and how to complete the CT-RACT
• Review and ensure holistic quality (e.g. risk grading has sufficient rationale, not responsible to ensure inclusion of the appropriate study risks)
• Review adherence to timelines and requirements
• Responsible for feedback on risks to protocol development
• Support the development of risk mitigation strategies
• Lead reviews of mitigation effectiveness.
• Analyse, summarize and report findings to inform future study design and library of mitigations.
• Track and oversee completion of mitigation actions – progress reports to CST
• Provide advice on the development of functional plans.
• Provide advice and input to functional plan updates - drive RBSE thinking
• Provide advice on linking risks to the standard KRIs, and identify study-specific KRIs
• Provide ongoing feedback for CT-RACT tool enhancements
• Support messaging, training and roll out of tool enhancements
• Extended member of the (G)CST:
• Agenda-driven attendance at Study Team Meetings for topics of CT-RACT, Functional Plan reviews, KRI identification

Qualifications:

• Doctorate degree
OR
• Master’s degree & 3 years of directly related experience
OR
• Bachelor’s degree & 5 years of directly related experience
OR
• Associate’s degree & 10 years of directly related experience
OR
• High school diploma / GED & 12 years of directly related experience

Preferred Qualifications:

• BS/BA/BSc in the sciences or RN
• 7 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company
• Experience of or oversight of outside clinical research vendors (CROs, central labs, imaging vendors, etc.)
• Experience as a Risk Manager, preferred