Clinical Quality Manager - Sponsor Dedicated

<p>Get ready to redefine what's possible and discover your extraordinary potential at Labcorp Drug Development. Here, you'll have the opportunity to personally advance health-care and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.<br /><br />Join us as we speed the delivery of ground-breaking therapies and anticipate tomorrow's drug development challenges, creating new possibilities for our clients-and your career.<br /><br />Labcorp Drug Development is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.</p><p></p><p>We have an exciting <b>Clinical Quality Manager</b> opportunity available in <b>Poland</b> to join our team. This is a <b>full-time</b> and <b>sponsor-dedicated</b> position.</p><p></p><p>The role requires the ability to follow current processes and procedures of the client but also the ability to improve processes and procedures. This position has a significant impact on the ability to conduct clinical trials in accordance with external and internal regulations and guidelines of the sponsor.</p><p></p><p><b>Role Details:</b></p><ul><li>Responsibility for the annual country specific QC plan, monitoring, and coordinating the implementation, and execution of QC plan in the respective country/US region according to the Client Standard Operating Procedures and ICH Guidelines and GCP</li><li>Responsibility for the management of the Client Corrective and Preventive actions (CAPA) of GCP audits and inspections in the country/US region at the Client level according to the Client Standard Operating Procedures and ICH/GCP Guidelines</li><li>Responsibility for the annual country specific quality plan, monitoring, and coordinating the implementation and execution of QC in the respective country/region</li><li>Responsibility to manage and/or co-lead key Client initiative charged with executing the continuous improvement</li><li>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</li><li>In cooperation with country functional area heads: ensures the Client CSOPs are checked /updated regularly; signs/authorizes CSOP deviations along with process owner</li><li>Responsible for all aspects of the quality site management as prescribed in the project plans</li><li>Local Quality and Process Improvement and training contact person- identifies local training demand, initiate local training needs and activities</li><li>Defines an annual country QC plan with collaboration to regional CQM</li><li>With mutual agreement with the functional areas will perform quality control (QC) activities and visits. Support on resolution of quality issues</li><li>Responsible for management and support audit preparation activities. In cooperation with country functional area person initiate state of the art root cause analysis for audit and inspection findings</li><li>Responsible for country trend analysis and impact assessments of audits and/or inspection findings</li></ul><p></p><p><b>Requirements:</b></p><ul><li>Substantial clinical research monitoring experience</li><li>Excellent study site management skills</li><li>Ability to work with minimal supervision</li><li>Good planning and organization skills</li><li>Ability to train and supervise junior staff</li><li>Ability to work within a project team</li><li>Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries</li><li>University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology</li><li>In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered</li><li>Fluent in Polish and English</li><li>Availability and willingness to travel to research sites</li><li>Valid Driver's License</li></ul><p></p><p><b>Labcorp is proud to be an Equal Opportunity Employer:</b></p><p></p><p>As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.</p><p></p><p>For <span>more information about how we collect and store your personal data, please see our </span><span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank">Privacy Statement</a></span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank"><span>.</span></a><span> </span></p>