Senior Project Manager / ICT Director Manager

Lead and develop a team of Application Managers, Project Managers, Report Managers, Safety System Support within Global Clinical Safety and Pharmacovigilance (GCSP)

• Define and uphold the mission and objectives of the entire Global Safety System unit

•  Lead, train, mentor, coach, and develop all members of the unit.

• Build an agile, vibrant, cross-functional and entrepreneurial global working environment within the group in order to keep personnel motivated and attrition rate low.

• Write/Evolve job descriptions and organizational structure/responsibilities as environment evolves overtime
• Manage Performance Management for organization within span-of-control

In the frame of a project, manage , coordinate, supervise and lead a pluridisciplinary project team made of Key Users, Business Expert, Vendor/external expert, IT expert, validation expert,...Manage budget, planning and ressource to go live in due time

• Manage/ Coordinate the development, validation and implementation of Global IT systems ,
• Manage/oversee/execute the preparation and maintenance of specific validation documentation
• Ensure appropriate access and training for all application users.
• Taking steps to maximize user satisfaction by monitoring performance and planning corrective actions for effective and efficient use of all designated applications
• Establish new processes and/or business needs and ensure development and documentation of global IT systems. Evaluate new software tools in function of future business needs. Analyzing various resource requirements and preparing implementation plan for the approved software application
• Track new developments in technology and assess their potential use in enabling business process improvements while assessing risks, costs and benefits of the new technology
• Ensure business needs/high projects deliverables according to agreed milestone business plan
• Influence new initiatives affecting business processes and ensure their documentation and accessibility
• Identify new regulatory requirements (e.g EU Directives, US, Japan, ...) and implement adequate adaptation of the business processes to ensure full regulatory compliance at any time
• Liaise with differetnt team to ensure a full effective communication of information throughout the company
• Liaise with business/contract partners to develop IT systems in GCSP (EU, US, Japan).
• Ensure objectives and benefits are realized through meeting

As a clinical data manager, my role was to track and commit to a database (Clintrial) the data gathered from clinical trials of new drugs. I ensured the completeness, accuracy and consistency of the data so that it meets the standards of quality expected for reporting to regulatory bodies. I was a key member of multidisciplinary teams (comprising of clinicians, statisticians, clinical research associates and quality managers) involved in setting up, running and reporting clinical trials.