Area: Clinical Document Management Systems
- Collaborate with external vendor and internal functions to:
- Build, expand and automate the migration approach for TMF documents from Source to Target System
- Oversee TMF Solution Implementation in the area of Document Management as well as TMF Metrics
- Collaborate closely with CDGM organisation and business process owners to ensure alignment of migration activities with parallel system and/or process updates.
- Engage with stakeholders to align on solution requirements, solution design and implementation as well as communication needs
- Support digital ambitions and gain insights on Artificial Intelligence projects
- 10+ years experience in Life Science Industry
- Extensive experience with usage of clinical document management systems
- Extensive experience as Project Manager
- Experience working as Business Analyst in Trial Master File and Document Management domain
- Working knowledge of clinical essential documents, including Trial Master File (TMF)
- Experience with coordinating deliverables from 3rd party vendors
- Knowledge of ICH GCP, 21 CFR part11
- Experience with Documentum based D2LS system is a plus.
- Experience with Document Migration Projects and TMF Metrics Projects is a plus
- Experience with Organizational Change Management is a plus
The above responsibilities are to a large extent based on interdisciplinary topics and require the employee to liaise, cooperate with and coordinate numerous related functions such as users from different business areas, CDGM functions, IT, QA, etc.