Jihene Duflos

Clinical Project Manager: Medical Devices (Freelance, since 2023)

Specialization MDR | ISO 14155 | Clinical Investigations

Since 2023, I have been working for EssilorLuxottica as a freelance clinical project manager on studies related to innovative medical devices, under the European MDR regulation and in accordance with the ISO 14155 standard.

I ensure the complete coordination of clinical investigations, in collaboration with the R&D, Regulatory Affairs, and Quality teams, on devices in the development or CE marking optimization phase.

Strategic management of the clinical study (setup, monitoring, closure)

Protocol writing and coordination, in conjunction with medical and technical experts

Regulatory submissions: CPP, ANSM, CNIL, in compliance with MDR

Budget supervision, contracts (investigators, hospitals, service providers)

Selection of service providers (CRO, Data Manager, Statistician, etc.) and kick-off meetings

Liaison with investigator sites: activation, recruitment, quality monitoring

Monitoring of device traceability, reporting and evaluation of deficiencies (Device Deficiencies)

Rigorous application of ISO 14155 requirements and MDCG guidelines

Contribution to the clinical compliance report for technical files

Senior Clinical Project Manager

15 projects managed

Budgets up to €2M

Supervision of 5 Clinical Study Managers

Sectors: Oncology • Rare Diseases • Vaccines • Immuno-inflammation

Experienced professional in conducting multicenter clinical studies in an international and regulated environment, from design to final report, including strategic management, team leadership, and quality supervision.

Study design and strategy in collaboration with medical teams

Coordination of stakeholders for protocol writing

Regulatory declarations (setup & closure)

Selection and management of service providers (CRO, labs, data, etc.)

Supervision of CRO kick-offs and deliverable tracking

Operational monitoring of sites: setup, recruitment, closure

Full budget management and reporting to Medical Department

Management of investigator contracts / hospital agreements

Supervision of a team of 5 clinical study managers

Coordination of CRAs (training, protocol specifics)

Recruitment of investigators and animation of the site network

Supervision of quality control and compliance with GCP

Internal audits, inspection readiness, and regulatory compliance

Monitoring of PV requirements (reporting, communication, compliance)

Contribution to the final clinical report

Liaison with Quality, PV, Legal, and partners

4 projects contributed to: Oncology • Inflammation & Immunology

Cross-functional support for the documentary, regulatory, and administrative management of several clinical studies, in liaison with project teams, investigator sites, and external service providers (CROs, suppliers, etc.).

Creation, monitoring, and quality control of the Trial Master File (TMF)

Collection and verification of essential documents throughout the study lifecycle

Monitoring of administrative and regulatory procedures (submissions, closures, DED)

Provision of key information to partner CROs: regulatory, administrative, logistical aspects

Liaison with investigator sites for contracting and logistical exchanges

Administrative management of sites: document tracking, agreements, status monitoring

Monitoring of service provider invoicing

Preparation of kick-off meetings

Contribution to final quality control, archiving, and project regulatory compliance