Clinical Quality and Training Manager at ICON plc

Key Responsibilities

• In line with corporate/regional/Clinical Development Centre (CDC) priorities, plan and conduct clinical quality assurance and clinical training activities to ensure that the relevant sponsors’ Clinical QMS (Quality management System) is functioning in compliance with ICH/GCP and local regulatory requirements in Clinical Development Centres (CDC) including the adjacent affiliates reporting to the CDC.
• The role requires the ability to properly implement local/global processes and procedures, to identify opportunities for process improvement and to support improvement initiatives. Be the local expert for ICH-GCP and local regulations and lead continuous quality improvement activities in CDC.

Clinical Quality:

• Plan and conduct activities within the Clinical Development Centre (CDC) to support Inspection/ Readiness at all times

Such as:

• Perform systematic quality checks for key activities such as protocol deviations, informed consent, TMF, etc.
• Ensure Inspection readiness package prepared for the high-risk sites in the CDC.
• Identify re-current issues and ensure preventive actions are implemented.

Quality Control/Compliance Activities
Coordinate Clinical QMR (Quality Management Review) activities in the CDC including:

• Tracking of QMR actions and focus area in CDC.
• Collects and monitors compliance issues and escalates, compliance issues including trends to the CDC.
• Performs root cause analysis if required.
• Developing local action plan and sharing of results and training of local affiliate, if required.
• Perform clinical quality and support visits (CQSV) to clinical trial sites in alignment with the regional/CDC/affiliate.
• Bachelor's Degree or equivalent in relevant health care area.

Experience:

• A minimum of 5 years of relevant experience in clinical research including direct field monitoring experience plus 2 years of QC Management experience.
• Knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
• Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
• Experience of participating in cross-functional teams of business professionals.
• Experience of participating in audits and inspections.
• Must have worked in a Clinical setting in Sub-Saharan Africa countries and be based in South Africa.
• 50% of role requires travel to Sub-Saharan Africa.