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Risk Based Quality Manager - South Yorkshire, United Kingdom - CK GROUP
Description
CK Group a recruiting for a Risk Based Quality Manager to our client on a permanent based at their midlands based site. Our client are a global pharmaceutical company that have a core focus on oncology, respiratory and neurological disorders.
What they are looking for some to have the responsibility for:
• 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.
Your Background:
To succeed as the Central RBQM Monitor, you have the following qualifications and work experience:
• 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
Compensation it dependent on experience, bonus, car allowance and healthcare benefits & pension scheme.
If you would like to apply fore this role or like more information please contact Rob Angrave on or email Please quote 56809 in all communications
Applicants must have full working right to work in the UK
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Job Overview
ID:
1093375
Date Posted:
Posted 2 days ago
Expiration Date:
08/05/2024
Location:
Nottinghamshire
Competitive
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