Achieva Group Ltd

Document Manager

Location
Basel
Salary
CHF55 - CHF62 per hour
Posted
11 Feb 2021
Closes
13 Mar 2021
Ref
BH-25453
Contact
Sophie Fosh
Discipline
Clinical Research
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
Our global pharmaceutical client has a vacancy for a Document Manager based in Basel.

Our client is looking for candidates based in Switzerland/ EU.

This is an initial 9 -month full time contract.

Job Purpose
Be 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.
 
Education:
  • Minimum Bachelor’s degree in life science/health care or equivalent
  • Languages:                        
  • Fluent English (oral and written), German of advantage.

 
Experience:
o             Thorough knowledge of clinical Trial Master File process, regulatory requirements and Good Clinical Practice, in particular for outsourced TMF filing activities
o             At least 4 years in clinical development/clinical operations
o             At least 2 years working experience with document management systems and excellent understanding of system structures and generic document management functionality
o             Advanced knowledge of clinical documentation and reporting
o             Good understanding of technical processes and PC environment including Microsoft suite of products
o             Knowledge of the national and international data protection legislation
o             Advanced ability to work independently
o             Experience with project work or project management in a global, cross-functional multicultural and international matrix organisation
o             Excellent communication, organisation and tracking skills
o             clinical research/ operations