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Clinical Systems Project Leader Belgium,  


Posted on : 15 April 2017

Project Description

Business LineConsulting ServicesJob DescriptionWe are looking for a Clinical Systems Project Leader for one of our clients based in Walloon Brabant. Scope: 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 ProfileEducation: 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 (e.g. 21 CFR Part 11) 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 offerYou 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 areKeyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research. At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services. Keyrus Belgium Offices: Chée de Louvain 88 - Waterloo-Lasne Rue Emile Francqui, 1 - Mont-Saint-Guibert Nijverheidslaan 3, - Strombeeck Bever CategoryData ManagementLocationWalloon BrabantContact person DD Diakho

Locations

Walloon Brabant Belgium

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