For one of our client located in Wavre, we are actively looking for a Clinical and Information Management Systems Project Leader.
- Do you hold a Master in Computer sciences or equivalent experience in ICT Skills?
- Do you have 3 to 5 years' experience in Clinical environment?
- Are you fluent in English?
Then you might be the candidate we are looking for! Don't hesitate and apply now.
As Clinical and Information Management Systems (CIMS) leader you are accountable for the computer systems supporting the human research development of new vaccines throughout their life cycle.
Within CIMS, the Project Leader is accountable for one or several computer systems:
- evaluation of new solutions and technologies;
- adoption of fit-for-purpose solutions;
- 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,…)
Project Manager 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 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.
- 2-3 years of experience with SAS in a Clinical environment
- Ideally 3-5+ years experience in Clinical environment
- SAS and SQL (mandatory)
- Business Objects, PL/SQL, Web services are assets
- Excellent knowledge of clinical development processes and tools.
- Experience in project management and computer systems development, validation and/or support.
- Mastering 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
Education, Methodology & Certification Requirements
- Master in Computer sciences or equivalent experience ICT Skills (software, operating systems, hardware, etc.)
- Programming or equivalent experience
- Microsoft Word
Language Proficiency Requirements
- English Fluent
- French is an asset