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Césaire SENECHAL

BALMA

En résumé

9 years of experience in Clinical Research including 5 years of Project Management in Phase II, III & IV International studies (including Phase III Paediatric study and Pivotal Registry study) and Management of Cohort Temporary Authorisation for Use in France (ATUc).
Therapeutic Area and Location Experience:
Ophthalmology, Oncology-Haematology, Virology, Anemia-Transplantation, Nephrology, Gastro-enterology, Diabetology, Endocrinology, Neurology in Europe (France, Belgium, UK, Spain, Italy, Germany, Austria, Portugal, Hungary, Denmark, Netherlands, Czech Republic, Switzerland) and ROW (US, India, Israel)

Mes compétences :
Industrial development
Virology
Ophthalmology
Oncology
Neurology
Nephrology
Investigator Contract negotiation
Haematology
Gastroenterology
Endocrinology
Clinical Trials
Clinical Research
Clinical Project Management
ATU de Cohorte
ICH-GCP

Entreprises

  • Santen SAS - CLINICAL PROJECT MANAGER

    2011 - maintenant Project Management of all aspects of International Clinical trials including Protocol and CRF writing, CRO choice, Contracts negotiations, Study Start-up, Logistics, Monitoring, Data Management, Statistics, Medical writing (Clinical Study Report) & study finance.
    Regulatory submissions: Ethics and IRB applications, awareness of and adherence to regulatory guidelines and timelines.
    Ensure Quality control of the project within deliverable timelines.
    Third party management including Medical supplies, External Laboratories, IVRS & e-CRF.
    Initiate and conduct periodic team meetings and /or conference calls to discuss the progress.
    Experience on GCP Inspections, Audits, Quality Control Checks and Co-Monitoring visits.
    Interactions with Pharmacovigilance and Regulatory Affairs departments.

    Management of Cohort Temporary Authorisation for Use in France (ATUc).

  • PAREXEL International - Sr. CLINICAL RESEARCH ASSOCIATE

    Paris 2005 - 2011 Coordinating clinical trial activities from site selection until site closure.
    Working with a variety of vendors to achieve the trial objectives within specified timelines.
    First Line of contacts for small team CRAs.
    Organizing and presenting Investigator Meetings and WebEx trainings. Lead international teleconferences.
    Review and sign-off of site visits reports. Study updates deliverables (trackers) provided to Sponsor.

    Site selection, Ethics committee submission, Investigator Contract negotiation and overcost, Site Initiation,
    Site Monitoring and Source Document verification, Site close out, Query handling, SAE reporting and Follow Up, Organization and accountability of clinical trial supplies, Follow Up study finances per site,
    Writing Study Progress report, Creation of study Documents, Maintenance of Trial Master File, Training of trainee CRA, attending International Team Meeting, Organizing Investigator Meeting.
    Experience on 6 International phase II and III studies and 1 International pediatric study.

  • Roche - CLINICAL RESEARCH ASSOCIATE Trainee

    Boulogne-Billancourt 2005 - 2005 Monitoring on 3 Phase III clinical trials: 31 co-visits (Roche SOPs), 37 days of field check
    - Treatment in metastatic cancer colorectal: Xelox vs Folfox (Local trail)
    - optimized treatment with enfuvirtide (Fuzeon®) among VIH-1 patients (Local trial)
    - Treatment with induction of Pegasys/Copegus among patients with chronic hepatitis C

Formations

Réseau

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