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France Keyrus Biopharma

Clinical System Manager M/F

Nouveau

Business Line

FSP

Job Description

We are looking for 2 «Clinical System Managers» M/F (junior and confirmed) to join our teams for the FSP department. The position is based in Île-de-France:

Main tasks:

  • Management of Computerized Systems Projects:
    • Production of Project Management Plan deliverable
    • Consolidation of the Users Requirements
    • Participation in the creation of the project Validation Plan as Writer, Reviewer or Approver
    • Participation in the creation of the Risks Analysis and evaluation of the projects impacts (IT, Business and Quality) as Writer, Reviewer or Approver…
  • Management of the Computerized Systems:
    • Management of user access and permissions on computerized systems
    • Management of user’s requests (feasibility, delay, cost, provider…)
    • Management of the change (risk, Impact, Installation Procedure, Test Plan, Recovery Plan…)
    • Non-conformities and CAPA management/follow-up over IT scope…

Profile

Required skills and qualities and expected level:

  • Being familiar with the following concepts: OS, Server Platforms, Storage, Network, Security, Databases, and Virtualization…)
  • Knowledge in various programming language
  • Knowledge of writing validation documents (V-diagram)
  • Autonomous
  • High sense of responsibility
  • Effective communication

Profile :

  • Master in Physiological Engineering, Biotechnology and Computer Science
  • Bioscience engineer, such as Sup Biotech
  • Minimum 3 years’ experience for the confirmed
  • Experience in pharmaceutical is a plus

Who we are

A major European player in clinical research, Keyrus Biopharma is a CRO (Contract research Organisation) created in 1998, which has 310 employees spread over 6 sites in France (Paris, Nantes and Lyon) and abroad (Belgium, Tunisia and Canada).

Keyrus Biopharma has directed its development strategy on innovation and creativity to offer its customers solutions with high added value. We specialize in all areas of clinical studies services: Regulatory submissions, feasibility studies, implementation and monitoring, data management, bio-statistics and medical writing. We intervene in the different phases of development, clinical phases I to IV, epidemiology and investigations.

To date, Keyrus Biopharma provides expertise and consultancy in all areas of clinical research based on its experience and has been able to adapt to the requirements of new environment/sectors such as nutrition, biotechnology, Cosmetology and medical devices.

Publication date

10.04.2019