Risk Based Quality Manager Monitor

• Execution and management of the Risk Based Quality Management [RBQM] processes in conformance to all relevant laws, regulations, guidelines, policies, and procedures.
• Leading cross-functional Clinical Study Teams in the completion of RBQM-related study start-up processes, such as protocol de-risking, Risk assessment and categorisation, and input into the monitoring strategy (e.g.: SDV targets) whilst keeping RBQM concepts central to all study activities.
• Provide leadership, operational expertise, training, and guidance as well as being a point of escalation for Central Monitoring issues related to RBQM system.
• Review, interpret and report data as an integral part of the Clinical Study Team in support of identifying centralised monitoring activities and/or investigator sites potentially requiring sponsor intervention.
• Support Clinical Study Teams in understanding the impact, criticality and potential root causes of the findings and defining appropriate follow-up actions.
• Contribute and participate to the ongoing development of the RBQM model and related processes in Clinical Trials.

• Minimum bachelor's degree and significant relevant biotechnology/pharmaceutical industry experience.
• Strong experience with Risk Based Quality Management processes.
• Leadership skills including the ability to work within a multidisciplinary team environment and influence adoption of RBQM concepts.
• Ability to operate and proactively use various systems and databases to analyze risk related to trial quality/performance and compliance and identify trends and early warning signals.
• Analytical problem solving/critical thinking abilities and experience.
• Working knowledge of clinical drug development process as well as ICH, GCP guidelines, regulations, and auditing procedures.
• Travel up to 20% internationally including seminars, conferences and kick off meetings

CK Group