Clinical Project Manager (CPM)
December 2006 --- August 2015
Domain: Immunology - Rheumatoid Arthritis; CNS - Epilepsy
- Manage study start-up, conduct and close-out. Co-ordinate efforts of cross-functional project teams to support key deliverables achievement within agreed timelines and according to cost constraints.
- Develop study tools to ensure the oversight of the study znd ifentify issues proactively, resolve/mitigate and escalate risks and/or issues.
- Lead rpoblem solving and resolution efforts to include management of risk, contingencies and issues.
- Provide project status on a regular basis and ensure appropriate escalation of risks, findings, and action plans to appropriate parties; ensure responses to key decision from appropriate parties.
- Identify quality issues within the study for implementing appropriate corrective action plans.
- Request and maintain team assignments; provide input to ine managers of their project team members'performance.
- Serve as primary project contact with CRO and vendors (central laboratory, IVRS) to ensure communication is maintained and milestones are achieved.
- Maintenance and update of trial management systems.
- Review and approval of study documents (protocol, study management plan, monitoring plan ...).
- Prepare and present project information at internal and external meetings.
- Coordinate audit responses.
- Ensure quality and adherence to the relevant Standard Operating Procedures, Good Clinical Practices and Regulatory guidelines.
Associate Clinical Trial Manager Brussels, Belgium
November 1997 --- November 2005
- Cross-functional study team management, i.e., management of a matrixed team, including Statistics, Data Management, Clinical Research Physician, European Subsidiaries, Regulatory Affairs, Drug supply, Outsourcing and contracts,etc
- Vendor management (CROs and central laboratories)
- Responsible for the budget and timelines management
- Study document generation/review and approval (Protocol, Monitoring guidelines, investigational and vendor contracts)
Clinical Research Associate (CRA)
November 1994 --- November 1996
November 1983 --- November 1993
ProactivityProblem solvingOrganizationFlexibilityWillingness to compromiseCoordinationAnalytical thinkingAttention to detail
BiochemistryClinical operationsClinical trial budgetingComplianceCRF designImmunology
Skills and Expertise
Master in psychology from mons Hainaut in 1993
Bachelor in biochemistry from Irschonwelz Ath - Belgium in 1982