Clinical Systems Project Leader - Belgium
Want to know company name or location? Company managed [?]
Role and main tasks:
- 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
- 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
- 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
- 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