Associate Project Data Manager - FSP

<h2>Job Overview:</h2><p style="margin-bottom: .0001pt;"><strong>Associate Clinical Data Manager / Associate Project Data Manager - FSP</strong></p><p style="margin-bottom: .0001pt;"> </p><p style="margin-bottom: .0001pt;">Joining Labcorp Functional Service Provider (FSPx) will offer a rewarding career, a chance to work in an energetic & team-oriented workplace, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning, to allow further progression to a Senior CDM position.</p><p style="margin-bottom: .0001pt;"><span style="font-size: 14.0pt;"> </span></p><p style="margin-bottom: .0001pt;">Our unique opportunity will allow you to bring your specialized discipline to a core team outsourced to a world class leading global healthcare company. Dedicated to our Client 100% of the time, you will play a key role in the drug development cycle and see a product through to launch with the support of both a dedicated Labcorp line manager and our client project teams.</p><p style="margin-bottom: .0001pt;"><span style="font-size: 14.0pt;"> </span></p><p style="margin-bottom: .0001pt;"><strong>Your role:</strong></p><p style="margin-bottom: .0001pt;"><strong> </strong></p><p style="margin-bottom: .0001pt;">The Associate Project Data Manager role is a great opportunity to work within our sponsor dedicated department and have this unique relationship with a sponsor. You will also assist across many areas of oversight in data management, on large scale projects.</p><p style="margin-bottom: .0001pt;"><span style="font-size: 14.0pt;"> </span></p><p style="margin-bottom: .0001pt;">In this role, you will:</p><ul><li style="margin: 0cm 0cm .0001pt 54.0pt;">Assist and lead operations team alongside Senior CDM, develop project documentation, system setup, data validation processes and procedures assigned to junior staff.</li><li style="margin: 0cm 0cm .0001pt 54.0pt;">As a lead data reviewer, you will perform all data operational tasks, ensuring quality standards are maintained.</li><li style="margin: 0cm 0cm .0001pt 54.0pt;">Work with Senior CDM to build study milestone timelines and be able to read and follow study timelines for on-time deliverables.</li><li style="margin: 0cm 0cm .0001pt 54.0pt;">Assist or lead internal and external DM meetings.</li><li style="margin: 0cm 0cm .0001pt 54.0pt;">Assist or lead to write, update/review and approve all required trial data documentation, including: Study-specific case report forms, CRF completion guidelines, DMP and Data Quality checks.</li><li style="margin: 0cm 0cm .0001pt 54.0pt;">Ensures study specific data transfer agreements are in place for all data vendors involved.</li><li style="margin: 0cm 0cm .0001pt 54.0pt;">Track scope changes and work with Senior CDM to ensure Sponsor approval is received and the scope change processed.</li><li style="margin: 0cm 0cm .0001pt 54.0pt;">Assist in the training of new staff on project specific DM processes.</li><li style="margin: 0cm 0cm .0001pt 54.0pt;">Coordinate with the DM study team to ensure all data related information is delivered within agreed timelines.</li><li style="margin-left: 54.0pt;"><span style="color: black;">Ensure all appropriate documentation and procedures are performed upon project completion for operations team. </span></li><li style="margin-left: 54.0pt;"><span style="color: black;">Attend client or internal audits as required and address client comments with the study team. </span></li><li style="margin-left: 54.0pt;"><span style="color: black;">Assist with the completion of Database Lock and Unlock activities with the Senior CDM. </span></li></ul><p style="margin-bottom: .0001pt;"><strong>What is FSP?</strong></p><p style="margin-bottom: .0001pt;">At Labcorp Drug Development, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).</p><p style="margin-bottom: .0001pt;"> </p><p style="margin-bottom: .0001pt;">As a Labcorp Drug Development employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Labcorp Drug Development has an FSP opportunity to match your area of expertise.</p><p style="margin-bottom: .0001pt;"> </p><p style="margin-bottom: .0001pt;">Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Labcorp Drug Development studies.</p><p style="margin-bottom: .0001pt;"> </p><p style="margin-bottom: .0001pt;">With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning. Further information can be found at: <a href="https://drugdevelopment.labcorp.com/services/functional-service-provider.html" target="_blank" rel="noopener"><span style="color: blue;">https://drugdevelopment.labcorp.com/services/functional-service-provider.html</span></a></p><h2>Education/Qualifications:</h2><ul><li style="margin-left: 54.0pt;">University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).</li><li style="margin-left: 54.0pt;">Additional relevant work experience will be considered in lieu of formal qualifications.</li></ul><p style="margin: 0cm; margin-bottom: .0001pt;"> </p><h2>Experience:</h2><ul><li style="margin-left: 54.0pt;">Experience in clinical data management as a junior DM or Senior CDA or similar.</li><li style="margin-left: 54.0pt;">Excellent oral and written communication and presentation skills.</li><li style="margin-left: 54.0pt;">In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.</li><li style="margin-left: 54.0pt;">Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.</li></ul><p style="margin: 0cm; margin-bottom: .0001pt;"><strong><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif; color: black;">MORE INFORMATION AVAILABLE ON REQUEST</span></strong></p><p style="margin: 0cm; margin-bottom: .0001pt;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif; color: black;"> </span></p><p style="margin: 0px;"><strong><u>Keywords:</u></strong></p><p style="margin: 0px;">Labcorp Drug Development, Covance by Labcorp, Covance, Chiltern, single sponsor, CRO, Contract Research Organisation, Contract Research Organization, pharma, pharmaceutical, clinical data manager, clinical data management, junior clinical data manager, Clinical Data Management, Clinical Data Management, home based, pharma, home-based, flexible working, flexible location, field based, home based EU Anywhere, anywhere in Europe, field-based, United Kingdom, UK, Great Britain, England, Maidenhead, Reading, Berkshire, Birmingham, Cambridge, Sheffield, Manchester, Alderley Edge, Scotland, Edinburgh, Wales, Swansea, Northern Ireland, Austria, Belgium, Bulgaria, Czech Republic, France, Paris, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Leiden, Poland, Portugal, Romania, Russia, Slovakia, Madrid, Barcelona, Spain, Ukraine, <strong><span style="font-family: 'Calibri',sans-serif; color: black; border: none windowtext 1.0pt; padding: 0cm;">#LI-Remote, </span></strong><span style="color: black; border: none windowtext 1.0pt; padding: 0cm;">Remote, EMEA</span></p>