After 17 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.
Barnett International 2018
Clinical Research Auditing Certification
Program geared toward individuals seeking a new career or transitioning into Good Clinical Practice (GCP) auditing. Case studies and industry best practices are presented to emphasize how the learning objectives apply directly to the responsibilities of the GCP auditor.
University Paris 7, France 2002-2003
Interuniversity Degree : training of investigators to clinical trials
Program geared towards individuals who want to start working in clinical research. It delivers a CRA diploma.
University Lyon 1, France 1996 - 1999
PhD in Human Biology
Thesis in Human Biology.
Work & Experience
Freelance GCP auditor, Senior CRA
Experienced Clinical Research Consultant with more than 17 years experience, with strang knowledge of GCP, EMA and FDA regulations. My company offers services : – Monitoring in French, Spanish and English-speaking countries – GCP investigational sites audits – Essential documents writing/review All phases, all therapeutic areas. www.sankbio.com
01/10/2011 - 01/18/2019
Senior Clinical Project Manager
Global Project Management of 3 international Clinical trials in Vaccinology/Immunotherapy. – Study budget and follow-up – Management of all vendors – Management of CRA teams – Responsible for the extension of an international phase II ongoing study to the US: feasbility, PSSV, SIV – Comonitoring in the USA and Mexico – Supervision of regulatory submissions • Phase IIb international clinical trial – lupus • Phase IIb international clinical trial – rheumatoid arthritis • Phase II international clinical trial – Crohn’s disease
04/11/2005 - 12/17/2010
Clinical Project Manager
Global project management of 3 clinical trials in Infectious diseases. – Management of vendors and CRA teams. – Co-monitoring in France. – Essential documents writing/review Academic sponsors: ANRS, NIH; and Private sponsor: Chiesi • Phase I/II national clinical trial – hepatitis B • Phase III & IV international clinical trials – HIV infection • Phase III international clinical trial – neonatal sepsis/meningitis
09/02/2002 - 04/08/2005
Monitoring of French, Spanish and Portuguese sites on phase III international clinical trials on HIV Academic sponsor : ANRS, NIH