Description
Migration Business Lead for Clinical trial documentation
1. Support the definition and refinement of the document management strategy for Documentation within a defined area of Clinical Development.
2. Design and/or oversee the process, system and tool landscape that supports the management GCP relevant documentation within a defined business process area. Manage system and/or process Implementation in collaboration with Business and IT Functions.
Experience:
- 10 + years working experience with document management systems (Documentum/ Documentum D2LS) and excellent understanding of system structures and generic document management functionality. Understanding of Veeva TMF and Veeva RIM is a plus.
- Experience in Pharma industry is must.
- Experience in Java, Python, Javascript, SQL, Oracle, Spark, MongoDB, Apache Shiro.
- 5+ years of hand on experience and thorough knowledge of clinical document management in TMF, Clinical and Safety areas.
- proven experience with large scale clinical doc migrations (ca. 6 million docs involved)
- Details understanding of DIA reference Model 3 to manage TMF documents.
- Experience of Artificial Intelligence and machine learning concepts and its applicability in clinical document management.
- Advanced knowledge of clinical documentation best practice guidelines & principles (good documentation practice, data integrity)
- Experience with Waterfall and Agile Scrum project management in a global, cross-functional multicultural and international matrix organization
- Excellent communication, organization and tracking skills
- English is a must, German is nice to have