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Senior Clinical Data Manager - Italy

Laboratory Corporation of America Holdings (Covance)

Italy

<h2>Job Overview:</h2><p style="margin-bottom: .0001pt;"><strong>Senior Clinical Data Manager - Italy</strong></p><p style="margin-bottom: .0001pt;"><strong>Home or office based</strong></p><p style="margin-bottom: .0001pt;"> </p><p style="margin-bottom: .0001pt;">Joining Labcorp Flexible Solutions (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.</p><p style="margin-bottom: .0001pt;"> </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;"> </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 Senior Clinical 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 be able to manage the oversight of activities 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-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To plan and drive the conduct of all Data Management activities for the assigned studies ensuring consistency with sponsor standards and regulatory guidelines.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To provide data management input and revision to study protocols.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To design/review mock CRF/eCRF contents ensuring consistency with Study Protocol.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To manage and guide providers, setting requirements, preparing the Request for Proposals and monitoring performance.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To ensure all data collection systems for assigned studies are setup, tested and fit for purpose according to expectations and timelines.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To review and approve CROs data management study documentation: Data Management Plan, database and data validation specifications, data transfer specifications, data reconciliation plan.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To collaborate in the definition of Protocol Deviations Plan and monitoring of protocol deviations during the study conduction.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To assist coding of medical terms and medical review.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To ensure data cleaning is performed by CROs in according to data validation specifications by the revision of appropriate listings or data quality checks.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To review database structure, annotated CRF and define.xml to ensure CDISC standards are properly implemented.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To define and proactively manage risks with potential impact on study systems setup, study conduction, or reliability of study results, including contribution of definition of Quality Tolerance Limits and Key Risks Indicators.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To lead the data quality evaluation, by the investigation of all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reports.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To coordinate cross-functional data review meetings managing the collection of data issues, reporting of findings and communication of post-review status.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To ensure database are locked according to regulatory requirements.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To regular monitor data management costs of the assigned studies ensuring respect of budget.</span></li><li style="margin-left: 18.0pt;"><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">To contribute to lessons learnt meeting at the end of the study, providing inputs to data handling procedures.</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>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></ul><h2>Experience:</h2><ul><li><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">Good knowledge of drug development processes.</span></li><li><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">Good data management expertise.</span></li><li><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">Solid knowledge of Good Clinical Data practices, GCP and regulatory requirements.</span></li><li><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">Experience of clinical databases, electronic data capture (EDC) systems, Interactive Response System, ePatient Reported Outcome (ePRO), and wearables and sensors to collect data directly from patients.</span></li><li><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">Good knowledge of Risk-Based approach.</span></li><li><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">In depth knowledge of Clinical Data Interchange</span><span style="font-family: 'Verdana Pro Cond Light',sans-serif;"> Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM) and Case Report Tabulation Data Definition Specification (Define.xml).</span></li><li><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">Good SAS programming.</span></li><li><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">High IT skills and good knowledge of FDA 21 CFR Part 11 and system validation.</span></li><li><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">Previous experience with Electronic Data Capture systems (in particular, Medidata RAVE and Business Intelligence tools.</span></li><li><span style="font-family: 'Verdana Pro Cond Light',sans-serif;">Advanced analytical and technical skills to interrogate and mine high volume of data from a variety of sources.</span></li></ul><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, Senior clinical data manager, Clinical Data Management, Clinical Data Management, home based, pharma, home-based, flexible working, flexible location, field based, gestione dei dati clinici, Parma, Rome, Milan, home based, Italy, <strong><span style="font-family: 'Calibri',sans-serif; color: black; border: none windowtext 1.0pt; padding: 0cm;">Remote, </span></strong><span style="color: black; border: none windowtext 1.0pt; padding: 0cm;">Remote, </span></p><p style="margin: 0px;"> </p>

Job posted: 2021-11-19

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