Associate Quality Manager - Clinical Monitoring

<h2>Job Overview:</h2><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: windowtext;">Covance is now Labcorp, and we are much more than a normal CRO.</span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"> </p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: windowtext;">We were named to </span><strong><span style="font-size: 11.0pt; color: windowtext;">Fast Company magazine’s list of 2021 Most Innovative Companies</span></strong><span style="font-size: 11.0pt; color: windowtext;"> for its leadership in scientific innovation </span><span style="font-size: 11.0pt; color: windowtext;">in the fight against COVID-19. Labcorp´s Drug Development Business, Covance, was recognized with the </span><span style="font-size: 11.0pt; color: windowtext;"><strong>2020 Global CRO Company of the Year Award</strong></span><span style="font-size: 11.0pt; color: windowtext;"> by Frost & Sullivan for our capacity to integrate digital technologies, remote monitoring, and telemedicine services to ensure continuity of and decentralizing clinical trials.</span></p><p style="margin: 0px;"> </p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: #0a0a0a;">We </span><span style="font-size: 11.0pt; color: #0a0a0a;">have supported the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. </span><span style="font-size: 11.0pt; color: #0a0a0a;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"> </p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: #0a0a0a;">Join us and see why Covance are uniquely positioned to offer you not only a job, but a stable, long-term international career, and why more than 90% of the top 20 global pharmaceutical companies are repeat customers.</span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: #0a0a0a;"> </span></p><p style="margin: 0cm 1.7pt .0001pt 0cm;"><span style="font-size: 11.0pt; color: #0a0a0a;">Main responsibilities:</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 10pt;">Vendor qualification</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">Vendor oversight (with participation to qualification and routine Audits)</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">Quality control check of Contracts with Vendors</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">First POC for IP Managers team</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">Communication with CROs</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">Workspace management</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">Review of BTD (Business technical documents)</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">SOP review (Sanofi Global asked for his support in reviewing study drug related SOP to align Pasteur – waiting for KOM expected shortly)</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 10pt;"><u>In addition</u>:</span></p><ul><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">Inspections/Audit preparation (currently FDA inspection on Fabri’s disease to prepare: waiting for news from FDA): no news about inspection plan</span></li><li style="margin-left: 36.0pt;"><span style="font-size: 10pt;">Extra-support to Mari Cidale/QA currently in place looking to re-organization and increased workload</span></li></ul><p style="margin-left: 36.0pt;"> </p><p style="margin: 0px;"><span style="font-size: 10pt;"><u>Potential extra tasks (involvement possible but not confirmed long term)</u><span style="color: #1f497d;">:</span></span></p><p style="margin: 0px;"><span style="font-size: 10pt;">Routine Audits for already qualified CROs</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">Relationship/communication with CRO about SOP review or new SOP</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">External account creation and management</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">Quality check on new study drug related SOP and if the case also new SOP related to other process/matter</span></p><p style="margin: 0px;"><span style="font-size: 10pt;">Following external consultant lawyer involvement about external provider/study drug destruction, 3 KPI defined -  relevant analysis expected quarterly.</span></p><h2>Education/Qualifications:</h2><p style="margin: 0px;"><span style="font-size: 10pt;">Certified CRA </span></p><p style="margin: 0px;"><span style="font-size: 10pt;">Able to commute twice per week to the office</span></p><h2>Experience:</h2><p style="margin: 0px;"><span style="font-size: 10pt;">Previous experience as a CRA & ideally performing Quality visits </span></p>