Clinical Project Manager at AARDEX Group (2021-11 – Present)
Manage the set-up, implementation and use of solutions in clinical trials according to Sponsor's requirements. Coordinate all stakeholders from internal kick off meeting to close out meeting.
- Manage the set-up, implementation and use of the solutions in the clinical trials according to Sponsor's requirements
- Coordinate all stakeholders from the Internal kick off meeting to the close out meeting
- Act as first line communication with the Sponsor
- Write dedicated project management plan and annexes
- Ensure a proactive support to Sponsor
- Ensure Clinical Team Training & Documentation
- Support Sponsor and users
- Manage complaints and queries
- Manage change requests
- Trigger the billing steps
- Collect and report feedback on improvement
- Manage data quality check and validation
- Update/Contribute to QMS documentation update
- Report on quality and procedure deviations
- Act as QA Manager main point of contact: Audit preparation and participation, SOPs redaction and updates
Project manager at Bridge2Health (2015-04 – 2021-11)
Primary resource and point of contact for the Customer and project team. Support the Customer through the whole development of its project (clinical & R&D projects).
- Primary resource and point of contact for the Customer and project team
- Support the Customer through the whole development of its project (clinical & R&D projects): Stakeholders identification, project set-up, contractual/financial aspects, ethics committee file redaction/preparation/submission, project management, logistics, project follow-up, invoices
- Human Bodily Material procurement regulations and contractual aspects management (Biobank laws)
- Manage H2020 and Interreg projects (project/budget set-up, project management, EU/Interreg electronic portals (i.e. OncoCare; BIOCYCLE))
Project coordinator at Medpace (2014-11 – 2015-04)
Compile and maintain project-specific status reports. Maintain project management databases and study timelines.
- Compile and maintain project-specific status reports
- Maintain project management databases (site supplies, site contacts) during all Study phases
- Maintain site payment schedule
- Create and maintain Study timelines
- Independently interact with the Sponsor, study centers, other contractors, and Medpace team
- Ensure all necessary Study documents are stored in document center
- Provide insightful input on Study-related documents (data analysis plan, final study report, etc.)
- Create the agenda and take minutes at meetings
Clinical Trial Assistant at Bone Therapeutics S.A. (2014-01 – 2014-11)
Assist the CPM in filing and archiving TMF documents. Prepare, handle and distribute Clinical Trial Supplies.
- Assist the CPM in filing and archiving the TMF documents (clinical study site documents, email correspondence, training materials and other study documents)
- Prepare, handle and distribute the Clinical Trial Supplies and maintain tracking information
- Perform administrative tasks
Intern for Research Projects at University of Liege (2011-09 – 2013-06)
Participate in PhD research projects on sleep, Parkinson's disease, cognitive ageing and alcohol stimulant effects.
- Centre de Recherches du Cyclotron: Participate in a PhD research about sleep, Parkinson's disease and cognitive ageing (recruitment, MRIs, cognitive screening, statistical analyses, scientific report)
- Psychological department: Participate in a PhD research about alcohol stimulant effects in human (recruitment, cognitive screening, statistical analyses and scientific report)