As a Clinical Quality Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Under the guidance of the Regional Director, Clinical Quality Management, the Clinical Quality Manager oversees all CQM activities in the respective country/cluster. The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CQMs support audits, inspections as well as Quality Control and local training activities. What you will be doing: Regulations & ProcessesLocal expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes)In close collaboration with local country operations management, manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs).Local expert for any quality-related local processes.TrainingLocal expert for any quality-related local processes.
In close cooperation with local country operations management, identifies / coordinates local training needs.
Quality Control (QC) ActivitiesIn conjunction with the local country operations management, coordinates and oversees all QC activities. This includes to ensure a proper execution of the In-house Quality Control Plan (IHQCP), the Quality Control Visits (QCVs) as well as any other QC Checks.
In mutual agreement with local country operations management and the RCQM, performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.
Audits & InspectionsPrimary local point of contact for MRL Quality Assurance and Regulatory Agencies.
Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection.In cooperation with local country operations and/or headquarters, performs root-causeanalysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates/facilitates the responses to audit/inspection reports. Quality / Compliance / Privacy Issue EscalationCommunicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM.Escalates significant quality/compliance issues and supports investigations (fact finding, root-cause-analysis) as well as the reporting of 'Serious Breaches', if applicable.Clinical Supplies GCP Investigations Evaluates trends on Clinical Supply GCP Inquiries and incorrect management of clinical supplies.Supplier QualificationLeads local supplier qualifications and re-qualifications of locally selected suppliers and supports solving of quality issues with locally selected suppliers.Supports the Quality Management System (QMS) assessment for local supplier qualifications and re-qualifications.
MRL Compliance & Privacy StewardSupports implementation of divisional compliance/privacy initiatives and reporting at the local level.
Global / Regional Key Initiatives / Projects You are: Bachelor's Degree or equivalent in relevant health care area. A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. Experience in Country Operations preferred.Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations.Solid track record of initiating, planning and delivery of projects and knowledge of project management practices. Demonstrated experience in leading cross-functional teams.Ideally, experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement.Ideally, experience in managing audits and inspections.Ideally, experience in coordinating and delivering training sessions.Superior oral and written communication and leadership skills in an international environment.Excellent project management, organizational and prioritization skills. Excellent teamwork skills, including conflict resolution expertise and discretion. Ability to analyze, interpret, and solve complex problems. Ability to think strategically, objectively and with creativity and innovation. Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results. Why ICON? Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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