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External Data Specialist - Clinical Data Management

Laboratory Corporation of America Holdings (Covance)

Maidenhead, United Kingdom

<p><b><u>External Data Specialist </u></b></p><p><b><u>Home or office based, depending on your location. </u></b></p><p><b><u>Description</u></b></p><ul><li>You will be permanently employed by <span>Labcorp Drug Development </span>working in our Functional Service Provider (FSPx) division, as an External Data Specialist.</li><li>You will work directly with one sponsor, within the External Data Service (EDS) team.</li><li>This role will be based in the EMEA and can be office or home-based.</li></ul><p></p><p>Join our growing team and discover your extraordinary potential by working as an External Data Specialist. If you are looking to strengthen your Clinical Data Management experience within a varied and dynamic environment, then this is a fantastic opportunity. The position offers a strong support network, flexible working solutions and the opportunity to progress your career.</p><p></p><p>You will support the Lead Data Manager with the review, maintenance and update of external vendor data received from the central vendor or local labs. The External Data Specialist will play a key role, as the demand for decentralised trials increases, you will work alongside the DM team providing metrics & reports. You will also be responsible for communicating with multiple vendors and have the opportunity to access new tools and review processes within the team.</p><p></p><p>Working within an experienced team, you will be assigned a mentor and be given a structured training path, in order to be successful in the role and to allow future career growth.</p><p></p><p>Some responsibilities will include:</p><ul><li>Ensure electronic vendor data contains all protocol-specified parameters, is in correct format and data populates to the specified fields and patients correctly.</li><li>Assist in the development of the Data Transfer Agreement and Data Transfer Specifications for vendor data transfers.</li><li>Review data discrepancies generated by study-specific edit checks for External data and perform the subsequent query management process in resolving the data issues.</li><li>Perform validation review of the electronically transmitted data for a sample of the total number of patients in the study for loading purposes.</li><li>Assist with review of External Data edit checks, External Data status reports, and External Data listings.</li><li>Interact with Clinical staff (CTM/CRA) to obtain local laboratory normal ranges for all sites. Research and resolve discrepant information concerning the normal ranges, and maintain proper documentation.</li><li>Enter and perform QC for local laboratory normal ranges. Verify the normal ranges are properly attached to the patient results in the local lab data collection module of the database.</li><li>Responsible as a contact person for the External source of electronic data transmissions.</li><li>Communicate to vendors and client problems involving data transfers, data point issues and validation issues.</li><li>Assist with review of draft protocols from an external data perspective and assist with review of eCRF design according to protocol parameters.</li><li>Participate/lead meetings with the study team, vendors and Sponsor.</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>Relevant experience will be accepted in lieu of degree.</li></ul><p></p><p><b>Experience </b></p><ul><li>Clinical data management experience required and/or significant experience surrounding the clinical trial process, specifically experience across various data sources.</li><li>Perhaps you have site or lab DM experience and now looking to gain more exposure.</li><li>Ideally you will have good knowledge/experience within study start up.</li><li>Ability to handle multiple tasks in a timely and professional manner under demanding conditions.</li><li>Ability to use standard Microsoft suite of software products.</li><li>Strong technical aptitude.</li><li>Ability to maintain confidentiality of data and information during interaction with staff at all levels.</li><li>Understanding of ICH-GCP principles.</li></ul><p></p><p><b><u>Keywords:</u></b></p><p>Labcorp Drug Development, Covance by Labcorp, Covance, Chiltern, CRO, Contract Research Organisation, Contract Research Organization, pharma, pharmaceutical, clinical data management, External Data, EDS, Clinical Data Management, Clinical Data Management, home based, decentralised trials, Vendors, vendor management, edit checks, ERT, epro, pharma, home-based, flexible working, flexible location, field based, home based EU Anywhere, anywhere in Europe, field-based, United Kingdom, UK, Great Britain, England, Bulgaria, Czech Republic, Greece, Hungary, Lithuania, Netherlands, Leiden, Poland, Portugal, Romania, Slovakia,  Bloemfontein, Centurion, South Africa, Madrid, Barcelona, Spain, <b><span>#LI-Remote, </span></b><span>Remote, EMEA</span></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: 2022-05-05

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