- GCP compliant design and performance of data management processes in compliance with CDISC standards
- Supervision of CROs concerning data management processes, e.g. Review and monitoring of data management plans, monitoring of query workflow, coordination of data transfers, backup and archiving of audit trail data
- Represent Data Management at clinical project meetings, negotiate timelines and Requests for Proposals (RfPs)
- Approves study-related documents and support archiving of receiving data transfers
- Development and maintenance of standardised procedures regarding data management processes
- Establish and maintain effective relationship with team members from global clinical operations and global clinical science for different projects
- Academic or higher non-academic in a technical or life science discipline.
- At least four years in Data Management or Data Processsing within drug development. However, a combination of experience and/or education will be taken into consideration.
- Detailed knowledge and experience with at least one EDC system, like RAVE or Inform, both in their set-up and reporting capabilities
- Proficient in computer applications like Microsoft Excel.
- Able to set and maintain data related standards, e.g. CDASH compliant.
- Excellent oral and written communication skills
- Ability to manage multiple projects on semi-autonomous way of working
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Data Manager - England, United Kingdom - Viatris
Description
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference. As a Data Manager - Global Clinical Operations (m/f/d) you will be responsible for coordination and performance of data management processes for clinical studies.
Key responsibilities for this role include:
The minimum qualifications for this role are:
At Viatris, we offercompetitivesalaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.