Senior Clinical Data Manager - Italian Speaker

Home or office based

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.

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.

Your role:

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.

In this role, you will:

• To plan and drive the conduct of all Data Management activities for the assigned studies ensuring consistency with sponsor standards and regulatory guidelines.
• To provide data management input and revision to study protocols.
• To design/review mock CRF/eCRF contents ensuring consistency with Study Protocol.
• To manage and guide providers, setting requirements, preparing the Request for Proposals and monitoring performance.
• To ensure all data collection systems for assigned studies are setup, tested and fit for purpose according to expectations and timelines.
• To review and approve CROs data management study documentation: Data Management Plan, database and data validation specifications, data transfer specifications, data reconciliation plan.
• To collaborate in the definition of Protocol Deviations Plan and monitoring of protocol deviations during the study conduction.
• To assist coding of medical terms and medical review.
• To ensure data cleaning is performed by CROs in according to data validation specifications by the revision of appropriate listings or data quality checks.
• To review database structure, annotated CRF and define.xml to ensure CDISC standards are properly implemented.
• 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.
• 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.
• To coordinate cross-functional data review meetings managing the collection of data issues, reporting of findings and communication of post-review status.
• To ensure database are locked according to regulatory requirements.
• To regular monitor data management costs of the assigned studies ensuring respect of budget.
• To contribute to lessons learnt meeting at the end of the study, providing inputs to data handling procedures.

What is FSP?

At Labcorp Drug Development, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).

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.

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.

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: https://drugdevelopment.labcorp.com/services/functional-service-provider.html
Education/Qualifications:

• 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).

Experience:

• Good knowledge of drug development processes.
• Good data management expertise.
• Solid knowledge of Good Clinical Data practices, GCP and regulatory requirements.
• 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.
• Good knowledge of Risk-Based approach.
• In depth knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM) and Case Report Tabulation Data Definition Specification (Define.xml).
• Good SAS programming.
• High IT skills and good knowledge of FDA 21 CFR Part 11 and system validation.
• Previous experience with Electronic Data Capture systems (in particular, Medidata RAVE and Business Intelligence tools.
• Advanced analytical and technical skills to interrogate and mine high volume of data from a variety of sources.

Keywords:

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