Clinical Computer System Validation Expert

Région
Wavre
Publication
vendredi 3 mars 2017
Date limite
lundi 3 avril 2017
Réf
67912XPE-BE
Contact
Andreea Ardelean
Fonction
Autre
Niveau d'expérience
5 à 10 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Clinical Computer System Validation Expert Organisation description:

For one of our clients, XPE Pharma & Science is looking for a Clinical Information Management System profile. This is a 10 months assignment at the client, with high possibility to be extended. At least 2 years of experience in the pharmaceutical industry as a Systems Validation Expert are mandatory.

Job description:
  • Reporting to the Innovation Project Leader, this technician will leverage his/her expertise in electronic systems validation to drive and support the implementation of new validated systems for data analysis of clinical trial data.
  • He/she will be responsible for contributing to a network of collaborations with colleagues working in different areas of expertise to drive the projects and foster new ideas.
  • Additionally, this individual will lead and engage in productive cross-functional relationships with various teams within the organization.
  • The job involves developing and communicating strategies and action plans in order to support the effective implementation of projects at different stages of development covering the area of clinical trials related systems.
  • For example, the person in this role might leverage his/her experience to design, implement and validate innovative solutions for computerized systems devoted to clinical trials data analysis.
  • Executes independently multiple technical projects
  • May supervise external technicians
  • Ensures accuracy of information provided
  • Ensures timely sharing of information
  • Follow established Health, Safety and the Environment policies. Actively participate in training, hazard identification and other HS&E programs
  • Understands data collection and reporting in the area of responsibility
  • Demonstrates knowledge of the key clinical activities and regulations
  • Takes major responsibility for the data generated by self and/or team
  • Contributes to implementation of project specific documentation and SOPs
Profile:

1. Minimum Level of Education* : Bachelor Area of Specialisation*: Data and Computer Sciences, Mathematics or Physics, Engineering or equivalent The role will require good understanding of computerized systems and technical validation issues in the pharmaceutical industry 2. Preferred Level of Education: Master Area of Specialisation: Data and Computer Sciences, Mathematics or Physics, Engineering or equivalent Should be able to independently write project documents, SOPs and to drive project progress Job-Related Experience Minimum Level of Job-Related Experience required: 2 years of experience in the pharmaceutical industry as a systems validation expert

  • The job requires skills in the design & validation of technological platforms in the field of clinical trials data analysis
  • The computational elements of the role require the use of sound judgment when proposing solutions.
  • The role requires to operate in a team based matrix environment with tight timelines and resource constraints
  • Problem solving and innovation are key for the project to go on according to agreed timelines
  • A disruptive innovation oriented mindset is fundamentals for working in R&D, ensuring the most effective techniques/models are being used

Other Job-Related Skills/Background:

  • Understand & implement processes specific to the vaccine R&D and to company with minimal bureaucracy and a focus on efficiency
  • Understand function operating procedures and/or internal policies required to maintain quality standards and to protect intellectual property
  • Fluent in English, oral and writing
  • Good communication skills, oral and writing
  • Ability to present data in front of an audience
  • Good project strategy skills
  • Team working oriented mindset
  • Ability to work under supervision
Offer:

Open end contract on XPE payroll; Opportunity to work in an international company



Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713