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CLINICAL SUPPLY SPECIALIST, EUROPE

Laboratory Corporation of America Holdings (Covance)

Sofia, Bulgaria

<p>IMPs don´t fall from heaven … IMP on site on time is the result of substantial coordination and planning.</p><p></p><p>This is what our <b>Drug Supply & Ancillary Supplies Specialists</b> live for: orchestrating the activities that will allow the entire clinical supplies lifecycle happen smoothly, no mistakes, no delays.</p><p></p><p>We have an opened several <b>Global</b> <b>Drug Supply & Ancillary Supplies Specialist</b><span> jobs</span> based in any of the following EMEA countries: <span><b>Poland, Romania, Bulgaria, Hungary, Greece, Czech, Turkey</b>. </span></p><p></p><ul><li>During COVID pandemic, the role is remote. After this period passes, the <span>job</span> most likely will be a hybrid office and home-based a few days a week.</li></ul><p></p><p><span>Labcorp is much more than a typical CRO:</span></p><p></p><ul><li><span>We were named to </span>Fast Company magazine’s list of 2021 Most Innovative Companies<span> for its leadership in scientific innovation in the fight against COVID-19. </span></li></ul><p></p><ul><li><span>We were also recognized with the </span>2020 Global CRO Company of the Year Award<span> by Frost & Sullivan for our capacity to integrate digital technologies, remote monitoring, and telemedicine services to ensure continuity of and decentralizing clinical trials.</span></li></ul><p></p><p>Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers.</p><p></p><p>We can offer you not only a <span>job</span>, but a stable, long-term international career.</p><p></p><p></p><h2><b>THE CLINICAL SUPPLY <span>JOB</span></b></h2><p></p><p>You will be accountable for the set-up and maintenance of all logistical activities around IMP/NIMP and Ancillary Supplies, from the issue of the protocol until final reconciliation. You will be implementing and monitoring the whole supply strategy, ensuring IMP are labelled, packaged, released and distributed in the best way to support the start and the quality of the whole Clinical Trial.</p><p>  </p><p>To thrive in this <span>job</span> you will:</p><ul><li>Translate study protocols into operational demand</li><li>Take ownership and drive IMP label development. The design and customization of core and country labels (at a global level) will be essential for your success, and the bread and butter of a normal day for you here.</li><li>Engage with primary and secondary packaging design and provide input to Drug & Ancillary Supply Forecasting projections, and IMP Distribution Plans, contracting and managing with Covance´s drug distribution external partners to make them happen.</li><li>Coordinate the regulatory and logistics aspects of importation</li><li>Ensure connection and alignment of the various stakeholders to ensure the delivery of IMP/NIMP and ancillaries on time at the right quality and within budget</li></ul><p></p><p>The reach of this <span>job</span> is global: from EMEA, you will provide global service, having a consultative role to client and internal teams also in the Americas and ASIA PAC, advising them on site storage, resupply, returns, drug inventory and expire date tracking processes. </p><p></p><p>EMEA #LI-REMOTE</p><p></p><p><b>QUALIFICATIONS</b></p><p><b>Our preferred profiles bring:</b></p><ul><li>University/College Degree AND <b>CRO-based</b> end to end (full service) clinical trial <span>supplies</span> management experience, ideally with regional/ global Supplies project management.</li></ul><ul><li>Thorough understanding of global drug development and the clinical trial project management process, with a special emphasis on investigator sites, patient recruitment and retention</li></ul><ul><li>Thorough and practical working knowledge of ICH-GCP Guidelines, Clinical GMP, including relevant international requirements/guidelines for the conduct of global clinical development programs</li></ul><p><b>Preferred:</b></p><ul><li>3 years Experience in Clinical Supply distribution/ GMP environment</li><li>Proven relevant clinical research experience in a pharmaceutical company/CRO, including clinical and ancillary supplies management responsibility.</li></ul><p></p><p><b>IS THIS YOU?</b></p><p>In this <span>job</span>, you will be doing much more than managing drug inventories… from pre-study activities to Drug Ready, through maintenance until destruction; providing global advice as internal expert, and working in collaboration with a wide range of teams needing your input for them to deliver (Clinical Trial Design & Strategy, Vendor Management, Quality Assurance, Business Development and Operations) – that´s you.</p><p></p><p>For that reason, <u>we need you to be able to independently interpret clinical protocols</u> and create your action plans out of that understanding, so you are familiar with:</p><ul><li>The different study and protocol designs</li><li>Drug formulation</li><li>Stability</li><li>Packaging/Labeling design and operations</li><li>Drug Supply Logistics</li><li>GMP – Annex 13</li></ul><p></p><p>This is why we are particularly interested in candidates who have developed that clinical research knowledge working in an international CRO, ideally with end to end (full service) clinical and ancillary supplies management, directly liaising with third party clinical supplies packaging and labeling projects. At least 3 years background in Clinical Supply distribution/GMP environment</p><p></p><p>Also important for this job is your experience in roles where you have had to inspire effective teamwork and motivate staff within a matrix system, so you excel at networking abilities.</p><p></p><p>You are an expert developing specifications for IxRS systems.</p><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>

Job posted: 2022-04-05

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