Clinical Document Manager

Beschreibung

• Responsible for efficient and appropriate management of GxP relevant clinical documents from creation through archival in compliance with applicable internal and external requirements for a defined business process area or project. Scope of this profile applies to Clinical Documents relevant for Regulatory Submissions.
• Support the definition and refinement of the document management strategy for Clinical Documentation relevant for Regulatory Submission, such as Clinical Trial Protocols, Clinical Study Reports, etc.
• Design and/or oversee the process, system and tool landscape that supports the management GCP relevant documentation within a defined business process ar-ea. Manage system and/or process Implementation in collaboration with Busi-ness and IT Functions.
• Act as Business Analyst/Lead to manage the implementation of Document Man-agement Related Applications:
  - Orchestrate business requirements across NVS and identify achievable business benefits
  - Coordinate and participate in system testing activities such as User Ac-ceptance and Performance Qualification Testing to ensure business bene-fits are reflecte
  - Support the design of training concept(s) and training material
• Provide input to technical teams for migration and support migration testing
• Plan, prepare and oversee rollout and change management activities (communication and training)
• Ensure deliverables comply with HA guidelines, Good Clinical Practices and inter-nal SOPs
• May act as Business Administrator in the electronic Document Management Sys-tem (eDMS) ensuring appropriate user access restriction, accurate &compliant document creation and document lifecycle management in close collaboration with system support and business functions.

• Education: Minimum Bachelor's degree in life science/healthcare or equivalent
• Languages: Fluent English (oral and written), German of advantage
• Thorough knowledge of clinical Trial Master File process, regulatory requirements and Good Clinical Practice, in particular for outsourced TMF filing activities
• At least 4 years in clinical development/clinical operations
• At least 2 years working experience with document management systems and ex-cellent understanding of system structures and generic document management functionality
• Advanced knowledge of clinical documentation and reporting
• Good understanding of technical processes and PC environment including Microsoft suite of products
• Knowledge of the national and international data protection legislation
• Advanced ability to work independently
• Experience with project work or project management in a global, cross-functional multicultural and international matrix organisation
• Excellent communication, organization and tracking skills