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Anne-Aurore PAIREL

Marseille

En résumé

Looking for a Senior CRA / Lead CRA opportunities.
Homebased, or office located near Marseille


With over 13 years of experience in the pharmaceutical industry as Lead CRA and monitor, I’ve a significant experience in the management and implementation of clinical research studies from phase II to IV in different therapeutic areas.

Skills and responsibilities:
 Study Coordination: International phase III studies
 Supervise CRAs’ activities (France & Europe): monitoring visits, CRF completion, queries resolution, sites’ contacts, CTMS updates, audits preparation, Investigational Product accountability
 Lead weekly meetings with sponsor and CRAs
 Lead the clinical monitoring team on a project, providing mentoring and ensuring the delivery of appropriate study specific and therapeutic training.
 Manage vendors (Central imaging, lab, IVRS, ECG…).
 Review monitoring reports and track ongoing site issues, provide recommendations and suggestions for issue resolution.
 Ensure that clinical staff assigned to specific clinical research projects complete tasks in accordance with the project contract, ICH-GCP and applicable regulations, and applicable SOPs.
 Interface with other project team members to ensure clinical monitoring deliverables are achieved.
 Supervise Regulatory & ethic submissions / approvals
 Supervise Contracts

Therapeutic aeras:
- Oncology
- Diabetology (adult & paediatric)
- Cardiology
- Gastro-enterology
- Urology
- Intensive Care (adult & paediatric)
- Ophtalmology
- CNS (paediatric)

Entreprises

  • AP-HM Assistance Publique - Hôpitaux de marseille - Hospital study coordinator

    Marseille 2015 - 2016 Manage study and patients' visits
    eCRF completion
    Manage SAE, study documentation

  • ICON clinical research - Study Start Up Team Lead

    2013 - 2014 Accountable for the development, implementation and execution of the Study Start Up Strategy from site identification (PSV) to SIV in all countries in assigned studies.
    Coordinating CEC/LEC, CA, MoH submissions, contracts and site activations on a global program as Regional Lead.

  • ICON Clinical Research - Lead CRA / Associate CTM

    2009 - 2014 Assisting management of the study in a study cross-functional team (clinical, data management, medical, IVRS, biostatistics, QA, central lab) and in an EU clinical team.
    Reviewing visit reports / follow-up letters;
    assuring training of team;
    accuracy of study CTMS;
    accuracy of assigned countries files;
    Approval of IP destruction form (ADF) review,
    global tracker updates,
    • Tasks also included frequent teleconference/contacts with sponsor (global or local), chair of routine teleconferences with CRAs and face to face, staff training

  • ICON Clinical Research - Senior Clinical Research Associate

    2007 - 2009 Monitoring activities (PSV, SIV, SMV, COV)
    in relation with data management and pharmacovigilance
    eCRF

  • Ferring SAS - Senior Clinical Research Associate

    2006 - 2007 Study Coordination – phases II, III & IV: CRF and protocol review, CRO overview , Authorities submissions, Budget and periodic report management, Investigator, hospital contracts Management, SOP revision
    Study phase III Management: Monitoring activities, SAE, CRF, study drug and material management

  • Lilly - Clinical Research Associate

    neuilly sur seine 2003 - 2006 International Studies phase III Management : Monitoring activities & Investigators sites management ; Preparation, organization and animation of Investigator meetings; Overhead cost evaluation, negotiation and management of contracts; SAE, CRF, study drug and material management

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