The primary service that can be offered by a freelance is its adaptation to new situation. My background in clinical research gives me the ability to fulfill a strict job description or provide services where your department and team need.
From the Request For Proposal to Final Report and Publications, I will be leading multifunctional teams through clinical studies in compliance with International Regulations.
- Vendors Selection and Management
- Site Selection
- Regulatory submission
- Study Documents
- Study Budget management
- Site and Vendors contract negotiations
- General Coordination and Oversight of Data Management, Safety reporting, complaint reporting, Device management.
- Coordination for publications and reports
As Lead CRA or Start-up Coordinator, I will be managing CRO or CRA to ensure the quality of deliverables within defined timelines.
- Support to regulatory strategy
- CRO management
- Site contract negotiations
- Preparation of submission dossiers
- Coordination of submission in Europe and Worldwide
- Development of monitoring plan and monitoring tools
- Ensure site and CRO compliance
- Preparation and Follow-up of site audits
- Co-monitoring visits
- Collaboration with Data Management for database development and data cleaning
When a situation becomes critical at study or site level, you need independent expertise to resolve with transparency and within timelines.
- Risk Analysis
- Corrective and Preventive Action
- Lessons learned sessions
Monitoring:
- In French and English
- Pre or post-market
- Full monitoring or risk-based monitoring with centralize activities
Submissions in France:
- ANSM
- CPP
- CNOM
- CCTIRS
- CNIL