About The Department/Company
Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines.
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.
Overview Of Job Role
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:
Clinical Data Management Specialist is responsible for ensuring that clinical trial data is accurate, complete, and reliable for statistical analysis and regulatory submission.
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.
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.
Scope and responsibility
- Manage end to end activities (study set-up, conduct and DB lock) and adherence to KPIs and timelines within studies of different complexities
- Supervise Study start-up, Design the eCRF, set up the eDC system, develop validation checks specifications, perform UAT
- Overview and test integration of EDC and IWRS systems
- Review Scope of Work and budget adherence
- Develop Data Transfer Agreements and perform reconciliation of electronic data received from other data sources, Safety database, labs, IRT, ePRO
- Communicate with project teams and vendors on data management matters
- Review data and manage queries to ensure quality
- Coordinate activities and availability of metrics leading to database lock
- Oversight of CRFs data entry and queries backlogs
- Create and maintain Clinical Data Management working files
- Act as an SME in reviewing different study documents (i.e. Study Protocol, Monitoring Plan, Medical Plan etc)
- Perform contemporaneous eTMF filing and QC checks
- Prepare and attend audits and inspections
- Support various Data Management teams on required tasks
- Review SDTM standards implementation (aCRF annotations, mapping, programming)
- Excellent verbal and written communication skills, flexibility, and can-do attitude
Job Requirements
- College/University degree
- Experience as a Clinical Data Manager (7+ years)
- Up to date on industry regulations (i.e. GCP, 21 CFR Part 11, GCDMP, EMA Guidelines on Computerized Systems)
- Experience with Clinical Data Management systems (i.e. Viedoc (considered as a plus), Veeva EDC, Medidata Rave etc.)
- Proficiency in MS Office applications
- Full working proficiency in English
- Organizational and time management skills
- Ability to work independently and multi-task
- CDISC: CDASH and SDTM knowledge
- SAS Enterprise Guide knowledge is a plus
