Highlights
Career highlights
A few concrete successes that illustrate the way we work:
anticipate, structure and deliver — from design to close-out.
Full set-up of a Clinical Oversight activity
Clinical Oversight Manager · since 2025Key achievement
End-to-end design and roll-out of the sponsor-side oversight activity.
- Documentation framework: Clinical Oversight Plan, update of all internal SOPs and Supportive Documents, documents to conduct Oversight Monitoring Visits
- Quality metrics tracking tools: CRA monitoring quality, site quality, EDC entry & queries, SAE notification timelines, overall safety follow-up
- Escalation paths to project management and governance set-up
- Concrete actions triggered: Oversight Monitoring Visits, investigations with the CRO and the sites, dedicated report reviews on top of routine review
Start-Up driven end to end for 11 sites
SSU & Contract Specialist · 2024-2025
Large-scale study under EU-CTR — phases I-II, oncology and ophthalmology.
Resolving a budget impasse in oncology
SSU & Contract Specialist · 2023-2024
Complex project (Convention Unique, EU regulations): 50% of the 16 sites refused the sponsor-approved budget — site activation was already delayed when the file was handed over.
- Budget grid revised for 8 sites, protocol amendment corrections integrated
- Renegotiation with all parties
- Situation fully untangled: amended contracts signed within a timeframe compatible with the study timeline
Turnkey CNIL declaration strategy
SSU & Contract Specialist · 2023
CNIL declarations to be secured while respecting the delegation of authority between CRO and sponsor.
- Reference methodologies declaration strategy developed and implemented
- Step-by-step guidance enabling SSU colleagues to submit in line with regulatory and contractual requirements
Regulatory qualification of a data-only study
SSU & Contract Specialist · 2021
French study involving patient data only, with no internal expertise available.
- Regulatory research and discussions with the French authorities: RNIPH classification confirmed
- Guidance to the sponsor and the team — regulatory pathway and Health Data Hub compliance secured
Monitoring recognised, assignment after assignment
Senior CRA & Clinical Trial Lead · 2014-2024
Ten years of monitoring at CROs and sponsors, from rare diseases to oncology.
- Praised by sponsor-side teams: responsiveness, autonomy, quality of deliverables
- Recommended on LinkedIn for monitoring expertise
- Visit reports singled out by the Clinical Operations Lead and the sponsor
- Team Lead responsibilities delegated and delivered successfully
- Recognised for knowledge sharing and managing pressure, including on a demanding oncology trial