Isabelle Rault
Senior Manager - Site Activation at Icon Plc
Based in Montreal, Canada
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Seniority
Manager
Department
Other
Location
Montreal
Industry
Biotechnology Research
Company size
34K
Contact information
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i•••••••@iconplc.com
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Background
About Isabelle Rault
I have over 16 years of study start-up (SSU) experience on North American and European studies. Responsibilities over the years included: regulatory document collection and review, country and site informed consent form development, ethics submissions as well as site contract and budget negotiation. Oversee start-up responsibilities including management of a high number of sites (at times exceeding 100 sites) as well as ensuring site activation timelines and commitments are met. Especially adept at: • Local and global clinical trials (Phase I – IV) in oncology, cardiovascular system, Endocrinology / Diabetes, Central Nervous System, ophthalmology, rheumatology, Uro-genital System, Gastro Intestinal System • Regulations (FDA and Health Canada) and ICH • Study Start Up • Working in Multidisciplinary environments • Managing complex and multidisciplinary teams • Providing regulatory support study (start-up related) to internal and external sponsors • Mentorship and SSU staff training • Contract and budget negotiations for various sponsors • Country-specific ICF development • Working in a priority-changing and fast faced environment
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