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Technical System Owner / Business Analyst - Belgium  

Keyrus Biopharma (company)


Posted on : 15 April 2017

Project Description

Job Description
We are looking for a Technical System Owner for one of our clients.

  • 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
  • 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
  • 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, ensuring the most effective techniques/models are being used  

 Role and main tasks
  • 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  

  • Bachelor or Master degree in Data and Computer Sciences, Mathematics, Physics or Engineering  

Required skills: 
  • Previous experience as in systems validation in the pharmaceutical area with knowledge in GCP
  • Good understanding of computerized systems and technical validation issues in the pharmaceutical industry
  • Able to independently write project documents, SOPs and to drive project progress
  • Understand & implement processes specific to the 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 the company's 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  

What We offer
  • You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
  • Each employee will be welcomed with a varied integration program. 
  • We invest considerable time and resources in training our staff (technical and non-technical courses). 
  • You will join a dynamic and international environment with enthusiastic and professional colleagues.

Who We are
Our company is a European full-service Contract research organization (CRO) providing biopharmaceutical, nutritional, cosmetic, animal health and medical device industries with a broad range of clinical research services from early- to late-stage clinical development, including project management, clinical monitoring, scientific and medical support, site management, biostatistics, data management, product safety, quality assurance, regulatory affairs, and medical writing.