Expertise: Senior Clinical Operations Manager
Operational management of your Phase I–III clinical trials — from feasibility to study closure
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
Management of feasibility, selection, initiation, monitoring, and close-out visits
Audit and inspection readiness
Drafting study documents (protocol, ICF, investigator brochure, questionnaires)
Drafting, reviewing, validating, and updating all clinical study plans
Contribution to clinical study reports, article publications, and scientific poster presentations at conferences
CTIS regulatory submissions, GDPR compliance for clinical trials, CNOM submissions, ethics committees
CNOM declarations, anti-gift law compliance, IDAHEV2 platform, Healthcare Transparency database
Management of investigational products (IMP)
Contribution to eCRF (electronic Case Report Form) design and UAT (User Acceptance Testing) validation
Validation and management of contracts (hospital, investigators, subcontractors, service providers)
Budget planning and monitoring
Coordinating all study stakeholders: sponsor, CRO, investigators, ethics committees, and service providers
Tracking and managing patient recruitment
Risk and quality management
Organization of scientific meetings, investigator meetings, and Data Safety Monitoring Boards (DSMB): expert identification, agenda setting, and minutes preparation
Collaboration with all cross-functional teams: Medical Affairs, Regulatory, Pharmacovigilance, Biostatistics, Data Management, and Operations.