Data Manager - Global Clinical Operations (m/f/d)
at Viatris
BHVDH, Hessen, Germany -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 30 Jul, 2024 | Not Specified | 01 May, 2024 | N/A | Consideration,Communication Skills,Drug Development,Microsoft Excel,Inform | No | No |
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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:
- 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
The minimum qualifications for this role are:
- 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
At Viatris, we offer competitive salaries, benefits and an 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.
Responsibilities:
Key responsibilities for this role include:
- 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 project
The minimum qualifications for this role are:
- 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 workin
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Clinical Pharmacy
Graduate
Proficient
1
Bad Homburg vor der Höhe, Germany