GCP Document Manager
Posted on Jan 7, 2021 by Michael Bailey Associates - UK Contracts
We have an exciting opportunity for an experienced GxP document manager to support a project in creating business processes related to Clinical Documents Management supporting regulatory submission.
1. 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.
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 process Implementation in collaboration with Business and IT Functions.
3. Act as Business Analyst/Lead to manage the implementation of Document Management Related Applications:
4. Support the design of training concept(s) and training material
5. Provide input to technical teams for migration and support migration testing
6. Plan, prepare and oversee rollout and change management activities (communication and training)
7. Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs
8. May act as Business Administrator in the electronic Document Management System (eDMS) ensuring appropriate user access restriction, accurate &compliant document creation and document life cycle management in close collaboration with system support and business functions.
Education: Minimum Bachelor's degree in life science/healthcare or equivalent
Thorough knowledge of clinical Trial Master File process, regulatory requirements and Good Clinical Practice, in particular for outsourced TMF filing activities
experience in clinical development/clinical operations
experience with document management systems and excellent understanding of system structures and generic document management functionality
Advanced knowledge of clinical documentation and reporting
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
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.