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Associate Clinical Data Manager - Early Phase

Laboratory Corporation of America Holdings (Covance)

Leeds, United Kingdom

<div><b>Associate Clinical Data Manager - Early Phase </b></div><div><div><div><div><p></p><p><b><u>Description</u></b></p><ul><li>You will be permanently employed by Labcorp Drug Development working in our Clinical Development Services (CDS) division working across a wide range of Sponsors and multiple therapeutic areas in Phases I to IIa.</li><li>Office based or home based anywhere in Europe or South Africa.</li><li>You must have previous experience of working in a clinical data management role within clinical research and ideally demonstrate some lead experience.</li><li>Candidates must be fluent in English language (both verbal and written).</li></ul><p></p><p>Join our growing team and discover your extraordinary potential by working as an Associate Clinical Data Manager within our Global Early Development department.  The CDS department works across multiple therapeutic areas in Phases I to IIa with multiple Sponsors.  The position offers a strong support network, flexible working solutions and the opportunity to progress your career. </p><p></p><p>If you are looking to strengthen your expertise within a varied and dynamic environment, then this is a fantastic opportunity. </p><p></p><p>In this role, you will:</p><ul><li>Assist and lead operations team alongside Senior CDM, develop project documentation, system setup, data validation processes and procedures assigned to junior staff. </li><li>As a lead data reviewer, you will perform all data operational tasks, ensuring quality standards are maintained.</li><li>Work with Senior CDM to build study milestone timelines and be able to read and follow study timelines for on-time deliverables.</li><li>Assist or lead internal and external DM meetings.</li><li>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>Ensures study specific data transfer agreements are in place for all data vendors involved.</li><li>Track scope changes and work with Senior CDM to ensure Sponsor approval is received and the scope change processed.</li><li>Assist in the training of new staff on project specific DM processes.</li><li>Coordinate with the DM study team to ensure all data related information is delivered within agreed timelines.</li><li>Ensure all appropriate documentation and procedures are performed upon project completion for operations team.</li><li>Attend client or internal audits as required and address client comments with the study team.</li><li>Assist with the completion of Database Lock and Unlock activities with the Senior CDM.</li></ul><p></p><p><b>Education </b></p><ul><li>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>Additional relevant work experience will be considered in lieu of formal qualifications.</li></ul><p><b>Experience</b></p><ul><li>Experience in clinical data management as a Lead DM or Senior CDA or similar within early phase trials.</li><li>Excellent oral and written communication and presentation skills.</li><li>In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.</li><li>Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.</li></ul><p></p><p><b>MORE INFORMATION AVAILABLE ON REQUEST</b></p><p></p><p><b><u>Keywords:</u></b></p><p>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, <b><span>#LI-Remote, </span></b><span>Remote, EMEA</span></p></div></div></div></div><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: 2022-06-10

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