Within a specific region, work together with Global Clinical Operations and the other regions in a joint effort to define and elaborate a Global Quality Control Plan and Risk Management Program to assist Clinical Operations to deliver a better compliance with relevant regulations and guidelines, including ICH and GCP. Lead the deployment and implementation of the Global plan including Risk Management in assigned region. Recommend and implement quality improvement initiatives dictated by the local context and needs within his/her region /countries. Coordinate and oversee Clinical Operations Quality Managers in the region in agreement with Local Management.
• Be a permanent member in the Clinical Operations Quality Management global forum representing assigned region.
• Contribute to the development of a Global Quality Control Plan and Risk Management Program, representing assigned region. This will include the processes, methodology and tools and any corrective action required on the global level.
• Participate in global working parties required by the development of the global quality plan, its follow-up, the monitoring of the implementation and measure of performance.
• Implement within the region the globally agreed Quality Control Plan, deploy Quality Managers across the region in agreement with Country Heads of Clinical Operations, oversee the following steps:
o planning and executing tasks
o risk identification
o risk assessment and ad hoc management
o corrective actions and guidance for improvement
o monitoring of compliance with the global strategy and evaluating the impact of the initiatives in the region.
• Create, develop, implement and deliver a regional/country Quality Control Plan and Risk Management Program adapted to local needs to complement the global strategy.
• Ensure adequate and dedicated communication with the Heads of Clinical Operations to get them engaged in the deployment of the strategy. Act as the conduit between the local offices within the region/country and Quality Assurance Services, attending ad hoc meetings/teleconferences as needed to exchange performance related data and information on quality issues and initiatives.
• Provide advice and support to Clinical Operations, including Project Managers, Line Managers, Learning and Development and Quality Assurance on all aspects of compliance, SOP development and customer requirements and to work closely together with operational teams to manage (e.g. review, escalate) quality issues, prepare corrective action plans, to follow these through until full resolution and provide adequate documentation within an appropriate time frame. This includes providing assistance during audits and regulatory inspections and partnering with Quality Assurance in case of suspicion of fraud or misconduct.
• Assume a customer facing role in the region for quality related issues.
• Be the primary contact with Quality Assurance for regional and/or strategic matters.
• Perform any other appropriate tasks as required by the role.
• Bachelor's Degree Bachelor's degree in life sciences or equivalent nursing qualification Req
• Minimum of 6 years experience in Clinical Monitoring with at least 2 years experience in a role equivalent to CTL; or equivalent combination of education, training and experience. Req
• Experience in Quality Management or Quality Assurance. Req
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