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.
Act as Business Analyst / Lead to manage the implementation of Document Management Related Applications :
o Support definition and orchestrate business requirements across NVS and identify achievable business Benefits
o Coordinate and participate in system testing activities such as User Acceptance and Performance Qualification Testing to ensure business benefits are reflected
o Support the design of training concept(s) and training material
o Provide input to technical teams for migration and support migration testing
o Plan, prepare and oversee rollout and change management activities (communication and training)
Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs
May act as Business Administrator in the electronic Document Management System (eDMS) ensuring appropriate user access restriction, accurate &compliant document creation and document lifecycle management in close collaboration with sys-tem support and business functions.
May act as Business System Owner or deputy for an eDMS or eDMS-related software application.
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 internal Clinical Operations functions, CRO representatives, IT.
Job Dimensions :
Compliance of GCP relevant documentation as well as efficiency of related processes :
Timely submission, delivery of high quality TMF documentation enabling regulatory compliance and applications for marketing approval.
External satisfaction, acceptability of clinical documentation by Health Authorities.
Efficient use of resources through operational effectiveness of document management and archiving
External reputation of NVS clinical documentation, with Health Authorities and in the document management and archiving community in general
Minimum Bachelor’s degree in life science / healthcare or equivalent
Thorough knowledge of clinical document management processes
Advanced knowledge of clinical documentation best practice guidelines & principles
good documentation practice, data integrity)
3-5 years in clinical development / clinical operations or similar business area
2-3 years working experience with document management systems and excellent understanding of system structures and generic document management functionality
Good understanding of technical processes and PC environment including Microsoft suite of products
Advanced ability to work independently
Experience with project work or project management in a global, cross-functional
multi-cultural and international matrix organisation
Excellent communication, organization and tracking skills
Work location : Basel
Workload : 100%
Salary : to be discussed
Language : Fluent English (oral and written), German of advantage
Ref : EW2626