
Helene Le Bihan
More than 12 years of experience in clinical trials from phase II to IV & observational survey: -Monitoring activities... | Medtronic, 9 BOULEVARD ROMAIN ROLLAND, France
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Helene Le Bihan’s Location Medtronic, 9 BOULEVARD ROMAIN ROLLAND, France
Helene Le Bihan’s Expertise More than 12 years of experience in clinical trials from phase II to IV & observational survey: -Monitoring activities from selection to close-out visits for international & national studies -coordination of investigators groups Therapeutic Experience • Neurology : Alzheimer, Insomnia and depression • Infectious Disease : Atypical pneumonia, Flu vaccine • Dermatology: Genital herpes • Rheumatology : Osteoarthritis • Cardiovascular : High blood pressure, prevention of cardiac insufficiency after myocardial infarction • Gastrointestinal: Colopathy • Endocrinology : Hypercholesterolemia, Diabetes • Urology : Prostate hypertrophy • General Medicine: Venous insufficiency • Gynaecology: Immunogenicity, HPV(Child) Freelance Senior Clinical Research Associate Field monitor experience: • Site management and performance according to ICH guidelines, local regulations, as well as FDA regulations (state and local laws), GCPs & SOPs. Site management activities include all in house and on-site monitoring for all visit types. • Site Selection including identification and feasibility. • Update study documents according to local specificities and regulation (Informed Consent Form, Study Drug Labels). • Perform the agreements with sites according to local specificities and regulation (investigator, institution and association contracts). • Monitoring visits including pre-study, initiation, ongoing monitoring and close out as required. • Performs all other sites monitoring activities (investigative site file reconciliation, Serious Adverse Event reporting, audits, study logistic and material). Specializations : Reactivity, suppleness and availability linked to a light structure as a Free-lance Clinical Research Associate allow to bring you an additional advantage in behavior and success of your trials.
Helene Le Bihan’s Current Industry Medtronic
Helene
Le Bihan’s Prior Industry
Printemps Evreux
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Soreclin Dr Spilthooren
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Sas Frehel
|
Lnarc
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Inventiv Health Clinical
|
Optum
|
Medtronic
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Work Experience

Medtronic
Clinical Research Specialist EMEA Neurovascular
Sun May 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Medtronic
Lead CRA
Tue Sep 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Apr 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Optum
Late Phase CRA
Sat Nov 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri May 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Inventiv Health Clinical
Coordinating Network Senior CRA, Freelancer Home-based in France
Fri Apr 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Apr 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Lnarc
Self Employed
Fri May 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Sas Frehel
Owner
Mon Aug 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Soreclin Dr Spilthooren
CRA
Sun Sep 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Apr 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time)
Printemps Evreux
Financial General Assistant
Wed Jan 01 1986 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time)