Description

<div><div>About the Department/Company </div><div>Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines. </div><div>Within Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities. </div><div>iCMR is launching an ambitious and exciting project aimed at modernizing and optimizing the departmental operating model. As part of this project, we are recruiting for the following position: </div><div> </div><div> </div><div>Overview of Job Role </div><div>Clinical Data Management Specialist is responsible for ensuring that clinical trial data is accurate, complete, and reliable for statistical analysis and regulatory submission. </div><div>They will actively contribute to fundamental data management activities throughout the entire lifecycle of a clinical study, from initial study setup to high-quality data collection and until the final database lock. </div><div>The Clinical Data Manager will be expected to work both independent and as an active part of a team, supporting all study stages and expected deliverables. </div><div> </div><div>Scope and responsibility </div><div><ul><li>Manage end to end activities (study set-up, conduct and DB lock) and adherence to KPIs and timelines within studies of different complexities </li></ul></div><div><ul><li>Supervise Study start-up, Design the eCRF, set up the eDC system, develop validation checks specifications, perform UAT </li></ul></div><div><ul><li>Overview and test integration of EDC and IWRS systems </li></ul></div><div><ul><li>Review Scope of Work and budget adherence </li></ul></div></div><div><div><ul><li>Develop Data Transfer Agreements and perform reconciliation of electronic data received from other data sources, Safety database, labs, IRT, ePRO </li></ul></div><div><ul><li>Communicate with project teams and vendors on data management matters </li></ul></div><div><ul><li>Review data and manage queries to ensure quality </li></ul></div><div><ul><li>Coordinate activities and availability of metrics leading to database lock </li></ul></div><div><ul><li>Oversight of CRFs data entry and queries backlogs </li></ul></div><div><ul><li>Create and maintain Clinical Data Management working files </li></ul></div><div><ul><li>Act as an SME in reviewing different study documents (i.e. Study Protocol, Monitoring Plan, Medical Plan etc) </li></ul></div><div><ul><li>Perform contemporaneous eTMF filing and QC checks </li></ul></div><div><ul><li>Prepare and attend audits and inspections </li></ul></div><div><ul><li>Support various Data Management teams on required tasks </li></ul></div><div><ul><li>Review SDTM standards implementation (aCRF annotations, mapping, programming) </li></ul></div><div><ul><li>Excellent verbal and written communication skills, flexibility, and can-do attitude </li></ul></div><div> </div><div>Job requirements </div><div><ul><li>College/University degree </li></ul></div><div><ul><li>Experience as a Clinical Data Manager (7+ years) </li></ul></div><div><ul><li>Up to date on industry regulations (i.e. GCP, 21 CFR Part 11, GCDMP, EMA Guidelines on Computerized Systems) </li></ul></div><div><ul><li>Experience with Clinical Data Management systems (i.e. Viedoc (considered as a plus), Veeva EDC, Medidata Rave etc.) </li></ul></div><div><ul><li>Proficiency in MS Office applications </li></ul></div><div><ul><li>Full working proficiency in English </li></ul></div></div><div><div><ul><li>Organizational and time management skills </li></ul></div><div><ul><li>Ability to work independently and multi-task </li></ul></div><div><ul><li>CDISC: CDASH and SDTM knowledge </li></ul></div><div><ul><li>SAS Enterprise Guide knowledge is a plus </li></ul></div></div>

Clinical Data Management Specialist

Description

Alvotech

Pipeline