Tasks & Responsibilities
- Support the definition and refinement of the document management strategy for Documentation within a defined area of Clinical Development.
- 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.
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.
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
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.