Clinical trial coordinator in front of pharmaceutical data screens

Expertise

Clinical Project Management & External DPO — I can intervene on one, the other, or both depending on your project

Clinical Project Management

I adapt to your needs, challenges, and deadlines with a constant and rigorous focus on quality and budget. With more than 25 years of experience, I identify risks very early and provide practical, actionable solutions. My involvement from the earliest phases of your project — protocol design, planning — allows us to establish a realistic timeline and better secure your study.

Services

Conducting and validating feasibility assessments

Drafting study documents (protocol, ICF, investigator brochure, questionnaires)

CTIS regulatory submissions, GDPR compliance for clinical trials, CNOM submissions, ethics committees

ICH-GCP compliance, SOP, international authority requirements (FDA, EMA)

CNOM declarations, anti-gift law compliance, IDAHEV2 platform, Healthcare Transparency database

Study team training and mentoring (PM, CRA, CTC, eTMF specialist)

Management of investigational products (IMP)

Management of feasibility, selection, initiation, monitoring, and close-out visits

Validation and management of contracts (hospital, investigators, subcontractors, service providers)

Drafting, reviewing, validating, and updating all clinical study plans

Coordinating all study stakeholders: sponsor, CRO, investigators, ethics committees, and service providers

Tracking and managing patient recruitment

TMF / eTMF creation, maintenance, and Quality Control

Risk and quality management

Budget planning and monitoring

Audit and inspection readiness

Organization of scientific meetings, investigator meetings, and Data Safety Monitoring Boards (DSMB): expert identification, agenda setting, and minutes preparation

Contribution to clinical study reports, article publications, and scientific poster presentations at conferences

Regulatory intelligence and monitoring for clinical trials: GDPR, FDA, EMA

Collaboration with all cross-functional teams: Medical Affairs, Regulatory, Pharmacovigilance, Biostatistics, Data Management, and Operations.

External DPO — Personal Data

As an External Data Protection Officer, I am independent of your organization, operating under a service contract to ensure compliance with regulations covering all your personal data, including health data classified as sensitive.

My expertise

My interest in data protection began in 2006. I regularly keep my knowledge up to date through recognized training programs, CNIL MOOC, and webinars. I have specialized knowledge of national and European legislation, and an in-depth command of the GDPR and the French Data Protection Act (loi Informatique et Libertés).

When setting up clinical studies in young biotech companies, I managed the processing register and supported teams on data compliance. Since 2018, I have implemented GDPR compliance for clinical studies in several biotech organizations, with hands-on experience in register management, procedure drafting, Data Protection Impact Assessments (DPIA), and data breach handling.

Engagement terms

Any organisation processing personal data must ensure compliance with French and European regulations. I support you in implementing and maintaining your GDPR compliance, whether for a one-off assignment or an ongoing engagement, adapted to the size and needs of your organisation.

My activities

Inform and advise organisations, whether they are data processors or data controllers

Promote a culture of data protection within your teams and your organisation

Monitor compliance with regulations

Conduct GDPR compliance assessments

Establish and maintain the personal data register

Analyze the processing register data

Carry out a Data Protection Impact Assessment (DPIA) for high-risk processing

Implement security measures and raise awareness among employees

Draft the annual DPO activity report

React immediately in case of a data breach

Analysis of data subject rights requests and assistance in drafting responses

Facilitate relations with the CNIL, particularly during audits or complaint handling

Provide recommendations on data retention periods