Country Clinical Quality Manager

<h2>Job Overview:</h2><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt;">Labcorp Drug Development has supported the pharmaceutical industry worldwide in developing more medicines than any other company, including the top 50 best-selling drugs on the market today. Our highly dedicated, supportive teams work on bringing drugs to market that have a real impact on the lives and health of people. </span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt;"> </span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt;">What we have to offer: a strong international support network, a genuine work-life balance, an attractive compensation package, great learning and career growth opportunities, and the chance to work with some of the most innovative pharmaceutical companies in the world.</span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt;"> </span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt;"> </span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt;">We are currently recruiting a Country Clinical Quality Manager (CCQM) in South Africa, who will be responsible for the annual country specific QC plan, monitoring, and coordinating the</span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt;">implementation, and execution of that QC plan. The role requires the ability to follow current processes and procedures of the dedicated Client but also the ability to improve processes and procedures. </span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt;">This position has a significant impact on the ability to conduct clinical trials in accordance with</span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt;">external and internal regulations and guidelines of the Client.</span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt;"> </span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt;"> </span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt;"> </span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt;">Job Summary:</span></p><p style="margin: 0cm 0cm 0pt;"><span style="font-size: 12pt;"> </span></p><ul><li><span style="font-size: 12pt;">Responsibility for the management of the Client Corrective and Preventive actions (CAPA) of GCP audits and inspections in the country at the Client level according to its Standard Operating Procedures and ICH Guidelines and GCP</span></li><li><span style="font-size: 12pt;">Responsibility for the annual country quality plan, monitoring, and coordinating the implementation and execution of QC </span></li><li><span style="font-size: 12pt;">The CCQM identifies local as well as global process improvement opportunities and training needs, and will be the local point of contact for all stakeholders ensuring appropriate training is implemented</span></li></ul><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 12pt;">University/college degree (life science preferred), or certification in a related allied health</span></li><li><span style="font-size: 12pt;">profession from an appropriately accredited institution, nursing certification, medical or</span></li><li><span style="font-size: 12pt;">laboratory technology</span></li><li><span style="font-size: 12pt;">In lieu of the above requirement, candidates with six (6) or more years of relevant clinical</span></li><li><span style="font-size: 12pt;">research experience in pharmaceutical or CRO industries will be considered</span></li><li><span style="font-size: 12pt;">Thorough knowledge of ICH Guidelines and GCP including a basic understanding of</span></li><li><span style="font-size: 12pt;">regulatory requirements</span></li><li><span style="font-size: 12pt;">Thorough understanding of the drug development process</span></li></ul><h2>Experience:</h2><ul><li><span style="font-size: 12pt;">Minimum of six-eight (6-8) years of clinical research monitoring experience (including prestudy, </span><span style="font-size: 12pt;">initiation, routine monitoring and closeout visits)</span></li><li><span style="font-size: 12pt;">Deep knowledge and understanding of Clinical Trial processes and quality management tools</span></li><li><span style="font-size: 12pt;">Demonstrated experience leading cross-functional teams of business professional</span></li><li><span style="font-size: 12pt;">Ability to proficiently interact with all levels of clinical research management and exert</span></li><li><span style="font-size: 12pt;">influence to achieve results</span></li><li><span style="font-size: 12pt;">Excellent site monitoring skills</span></li><li><span style="font-size: 12pt;">Excellent study site management skills</span></li><li><span style="font-size: 12pt;">Good planning and organization skills</span></li><li><span style="font-size: 12pt;">Excellent verbal and written communication skills</span></li><li><span style="font-size: 12pt;">Ability to train and supervise junior staff</span></li><li><span style="font-size: 12pt;">Ability to resolve project-related problems and prioritizes workload for self and team</span></li><li><span style="font-size: 12pt;">Ability to work within a project team</span></li><li><span style="font-size: 12pt;">Works efficiently and effectively in a matrix environment</span></li></ul>