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Sylvie MINS

LONDRES

En résumé

After 13 years in Clinical Research withbextensive experience from CTA to Lead CRA and International Study Coordinator, I'm now a Free Lance CRA based in London. I'm able to fully manage your clinical trials in UK, Scotland, Ireland, France, Switzerland, Belgium - English and French speaking areas.

Mes compétences :
Oncology: breast, ovarian, lung, head and neck can
Haematology: Multiple myeloma, Amyloidosis, Purpur
Orphan diseases: mucopolysaccaridose, Lambert Eato
Dermatology and Onco-Dermatology: Actinic keratose
Paediatry: Vaccines
Gynaecology: Hemorragic myeloma
Endocrinology: Acromegaly, Diabetes
Infectiology: Co-infection HIV-Hep C, Hep B
Cardiology: HTA, Hypercholesterolemy, Atherosclero
Gastroenterology: Crohn disease
Rheumatology
Immunology
Phases I to IV and Late Phase Studies
E-CRF: Rave, Inform
Vendors management: Central lab, Drug suppliers, C
Pharmacy and Drug management as U-CRA
Co-Monitoring, CRA Assessment, CRA Training
Investigator meeting presentations
Legal agreements: Investigators, Institutions, Ven
Regulatory submissions (France, UK, Belgium, Switz
Monitoring in English and other european languages
Audits: Sites and TMF
Feasibility and Site Selection

Entreprises

  • SM ClinOps, Ltd (ex-KaiKen Clinicals) - Free Lance CRA, Home based in London, UK

    2012 - maintenant Full management of clinical studies:
    - Head and Neck cancer for French sites
    - Multiple Myeloma for French sites
    - LEMS for sites in France and Germany
    - Mucopolysaccharidosis for sites in France, Germany, Austria, Italy, Netherlands, Norway, Lithuania

  • TRIO - Senior CRA

    2011 - 2012

  • ICON Clinical Research - Senior Clinical Research Associate

    2010 - 2011

  • KENDLE - LCRA

    2007 - 2010

  • KENDLE - International Study Coordinator (part-time, outsourced)

    2006 - 2008 Coordination of 2 Phase IIIb studies in dermatology and rheumatology, performing all regulatory submissions, legal agreements (investigators, hospitals, vendors), managing drug import licences flow, follow-up of study participants and payments (investigator fees and patients reimbursements), coordinating activities between local CRAs and Wyeth France, communication flow between Wyeth France / US and Kendle concerning all above topics.

  • KENDLE - International Study Coordinator (part-time, outsourced)

    2006 - 2008 Coordination of 2 Phase IIIb studies in dermatology and rheumatology, performing all regulatory submissions, legal agreements (investigators, hospitals, vendors), managing drug import licences flow, follow-up of study participants and payments (investigator fees and patients reimbursements), coordinating activities between local CRAs and Wyeth France, communication flow between Wyeth France / US and Kendle concerning all above topics.

  • KENDLE - CRA 2

    2006 - 2007

  • Pflizer - GEC

    2003 - 2006

Formations

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