Keywords
Skills
After 16 years in clinical research, mainly as a project manager and CRA in biotech companies and CROs, I have decided to start a new career as a freelance GCP Auditor/senior CRA. I was certified in November 2018 by Barnett International and I have conducted a few GCP investigational site and GcLP co-audits so far. Barnett International delivers a training which is FDA and BIMO inspections-focused.
When creating my own company San.K.Bio Consulting, I developed robust auditing techniques and tools, based on my experience in clinical research and on my Auditor training. My biggest assets are my strong knowledge of both European and FDA regulations, and the variety of my experience in clinical trials. Since the beginning of my career, I have also been actively involved in Quality Assurance, writing SOP, managing and reviewing CAPAs. Detailed-oriented, I have always had high standards in my work and improved the quality of the projects with which I have been involved.
My company San.K.Bio Consulting also provides monitoring services and essential documents review. I have been monitoring clinical studies in various countries of the world (France, Spain, Portugal, Mexico, USA) and my high communication skills enables me to rapidly adapt to any new project. My experience as a lead CRA and project manager made me understand the larger context of the monitoring effort. I have more than 14 years’ experience in visit reports’ review written by CRAs from worldwide, and I can perform a thorough review of your CRAs’ monitoring reports, ensuring they deliver a high quality final report, that will give an accurate and clear picture on how the clinical study is handled at the site. Finally, since I have been involved in writing and review of thousands of essential documents since the beginning of my career, I can give a take a fresh look at your documents and bring a critical eye on protocols, CRFs, ICFs, subjects facing documents etc.
When creating my own company San.K.Bio Consulting, I developed robust auditing techniques and tools, based on my experience in clinical research and on my Auditor training. My biggest assets are my strong knowledge of both European and FDA regulations, and the variety of my experience in clinical trials. Since the beginning of my career, I have also been actively involved in Quality Assurance, writing SOP, managing and reviewing CAPAs. Detailed-oriented, I have always had high standards in my work and improved the quality of the projects with which I have been involved.
My company San.K.Bio Consulting also provides monitoring services and essential documents review. I have been monitoring clinical studies in various countries of the world (France, Spain, Portugal, Mexico, USA) and my high communication skills enables me to rapidly adapt to any new project. My experience as a lead CRA and project manager made me understand the larger context of the monitoring effort. I have more than 14 years’ experience in visit reports’ review written by CRAs from worldwide, and I can perform a thorough review of your CRAs’ monitoring reports, ensuring they deliver a high quality final report, that will give an accurate and clear picture on how the clinical study is handled at the site. Finally, since I have been involved in writing and review of thousands of essential documents since the beginning of my career, I can give a take a fresh look at your documents and bring a critical eye on protocols, CRFs, ICFs, subjects facing documents etc.
Project history
San.K.Bio Consulting, Freelance GCP Auditor/Senior CRA, February 2019 - present
Neovacs, Clinical Project Manager, January 2011 – January 2019
- Monitoring of clinical trials
- GCP Audits
- Essential documents writing and review
Neovacs, Clinical Project Manager, January 2011 – January 2019
- Global project management of 3 international clinical trials
- Vendor assessment and management
- Supervision, ongoing training and support of CRAs
- Co-monitoring in the USA and Mexico
- SOP writing under QA direction
- CAPA (vendor and clinical site) management
- Co-audits with QA manager (GCP site and GcLP)
- Essential documents writing/review and CRAs’ trip reports’ review
- Organization, preparation of steering, adjudication committees and DSMB.
- Global project management of 3 international clinical trials
- Vendor assessment and management
- Management of a team up to 4 CRAs
- SOP writing under QA direction
- Essential documents writing/review and CRAs’ trip reports’ review
- Reporting/Presentations to steering committees.
- Monitoring of international phase III clinical trials in France, Spain and Portugal
- SOP writing under QA direction
- Data capture
- Coding under Medical Monitor’s Supervision
Local Availability
Only available in these countries:
France
I live between France and the USA. I am flexible to travel and work in these 2 countries.
For monitoring activities, I only accept travelling up to 50%
For monitoring activities, I only accept travelling up to 50%
