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Clinical Systems Project Leader Belgium,  

Keyrus Biopharma (company)

Posted on : 15 April 2017

Project Description

Job Description
We are looking for a Clinical Systems Project Leader for one of our clients.

The team is accountable for the computer systems supporting the human research development of products in the company throughout their life cycle. 

Role and main tasks
Within the team, the Clinical Systems Project Leader is accountable for one or several computer systems: 
  • evaluation of new solutions and technologies
  • adoption of fit-for-purpose solutions for the company 
  • adaptive and corrective maintenance of existing applications
  • decommissioning of obsolete systems  and the underlying activities, in collaboration with key business users: 
  • definition of user requirements
  • validation of systems in collaboration with IT Risk and Compliance
  • roll-out to end-users (implementation plan, process document, training, &)
  • support of end-users (helpdesk, &)  

The Clinical Systems Project Leader is accountable for : 
  • system fit with the company's requirements and industry standards
  • system compliance with international regulations (ICH GCP, 21 CFR Part 11) and the company's policies
  • process documents supporting the use of the system in a regulated environment
  • training and support of end-users
  • respect of planning and budget  

  • Master in Computer sciences or equivalent experience  

Required skills: 
Hard skills:  
  • Previous experience in Clinical environment
  • Excellent knowledge of clinical development processes and tools
  • Applied knowledge of validation methodology
  • Understanding of GCPs, principles of validation and other applicable regulations 

Soft skills:  
  • Leadership skills and relationship management, including negotiation capability, conflict resolution and consensus building, positive team spirit induction and interpersonal skills
  • Ability to influence performance in a matrix organization through negotiation and communication
  • Excellent communication and presentations skills, ability to facilitate interfaces within extended network, proven experience in negotiating and influencing at different levels of the organization
  • Ability to lead courageously, with both flexibility and a sense of urgency (high pressure and conflict of priorities)
  • Ability to anticipate for changes that may be needed based on the external regulatory environment.
  • Understanding of cultural diversity, experience in international settings  

ICT and Language skills:  
  • Web services
  • SAS
  • Technologies SQL
  • English fluent  

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.


Walloon Brabant Belgium

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