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Summary

I am well-organized, efficient, flexible, life science graduate with ten years clinical research experience in phase I, II, III(b), post reimbursement international studies, in a wide range of therapeutic areas (oncology, cardiology, neurology, dermatology, ophthalmology, rheumatology, gynecology and medical devices). As a Clinical Research Associate, I could understand all these years (six and a half years) the activities inherent to the profession: feasibility study and selection of investigators; attendance to investigator meetings; co-ordination of ethics committee and regulatory authority applications and approvals; initiation, monitoring and close-out of study sites; fees management.
With these recent years (four and half years of experience as a project manager), I provide qualified training and coaching for the monitoring teams (CRA, CTA) with regard to ICH-GCP, protocol, case report forms and study specific procedures including review and approval of monitoring reports; in order to insure timely study start-up and achievement of study targets. Furthermore, I could develop my management experience on regulatory, financial (manage project budget), logistical (vendor oversight), administrative and organizational (lead experts committee meetings) aspects.

Experiences

Current Experience

  • Clinical Project Leader – Medical Devices Issy-les-Moulineaux, France
    Since November 2014

    Responsibilities:

    • Writing, review and preparation of studies documents (protocol, ICF, CRF) and study tools (tracking tools, monitoring plan).
    • Coordination of local regulatory and ethical requirements.
    • Managing of study budget and contracts negotiations.
    • Organizing and animation of experts committee.
    • Conduct co-monitoring visits.
    • Review and approval of monitoring reports.
    • CROs management.
    • Act as a trainer and mentor for clinical staff (CRAs, assistants)

     

    Therapeutic areas: Neurovascular (7 sites, 167 patients, 366 K€);

                                   Orthopedic: Study 1 (18 sites, 233 patients, 245 K€)

                                                       Study 2 (6 sites, 102 patients, 465 K€)

Past Experience

  • Clinical Operations Project Manager Suresnes, France
    June 2014 --- November 2014

    Responsibilities:

    • Identification of coordinators/investigators feasibility study, site assessment.
    • Review/creation of study documents.
    • Coordination of local regulatory and ethical requirements.
    • Coordination of financial aspects: contracts (site, pharmacy...), follow-up of payments.
    • Conduct co-monitoring visits.
    • Review and approval of monitoring reports.
    • Overseeing day-to-day activities of monitors to ensure a focus on quality and timelines is reached and maintained.
    • Liaison with Therapeutic Division and Biometry.
    • Act as a trainer and mentor for clinical staff (CRAs, assistants).

     

    Therapeutic areas: Cardiovascular, Ophthalmology, Rheumatology

  • Clinical Project Leader Tunis, Tunisia
    February 2013 --- July 2013

    • Makes decisions on recruitment/selection of potential investigators and vendors.
    • Coordinating a clinical trial within the contractual timelines, deliverables and financial obligations.
    • Project Start-up leader: ensure execution and coordination of regulatory submission activities, logistical aspects, organization of IM, budget negotiation, vendor selection, drug supplies, contract establishment and collection of essential documents to get sites ready for initiation within agreed timelines.
    • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
    • Act as a trainer (delivery of GCP training’s) and mentor for clinical staff.
    • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
    • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
    • Conduct co-monitoring visits to manage data backlog, site compliance and quality issues.
    • Review and approval of monitoring reports.

      Therapeutic areas: Cardiovascular, Dermatology

  • Clinical Research Specialist Levallois-Perret, France
    July 2010 --- January 2013

    Responsibilities : 

    • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
    • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
    • Act as a trainer and mentor for clinical staff. Conduct quality assessment and training visits for a variety of protocols and study teams.
    • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
    • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.
    • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
    • Managing of study budget and contracts negotiations.
    • Create tools, procedures and processes for study team to ensure quality monitoring.
    • Ensure that new project CRAs are brought on board and receive relevant study information.
    • Conduct co-monitoring visits to manage data backlog, site compliance and quality issues, may be beyond home geography.
    • Ensure that clinical monitoring tasks are conducted in accordance with protocol, process, quality standards and expectations, per contract.

    Therapeutic areas: Cardiovascular, Neurology

  • Senior Clinical Research Associate Rueil-Malmaison, France
    November 2007 --- July 2010

    Responsibilities:

    • Makes decisions on recruitment/selection of potential investigators and vendors.
    • Prepared financial contracts for investigators.
    • Negotiate agreement with hospital administration.
    • Co-ordination of ethics committee and regulatory authority applications and approvals.
    • Initiation and monitoring of study sites (pharmacy, laboratory and investigators).
    • Fees management.

    Therapeutic areas: Cardiovascular, Neurology

  • Clinical Research Associate (CRA) Rueil-Malmaison, France
    January 2006 --- November 2007

    Responsibilities:

    • Feasibility study.
    • Selection of investigators.
    • Initiation and monitoring of study sites (pharmacy, laboratory and investigators).
    • Query management.
    • Fees management.

    Therapeutic areas: Cardiovascular, Oncology

  • Clinical Research Associate (CRA) 11th arrondissement of Paris, Paris, France
    January 2005 --- December 2005

    Responsibilities:

    • Feasibility study and selection of investigators.
    • Study documents development (protocol, CRF, TMF, ISF)
    • Co-ordination of ethics committee and regulatory authority applications and approvals.
    • Initiation, monitoring and close-out of study sites.
    • Order and co-ordination study supplies (materials, study documents, treatments)
    • Central point of contact for the complete study team.
    • Fees management.

    Therapeutic areas: Cardiovascular, Gynecology

Personality

Self Assessment :
Attention to detailFlexibilityCoordinationCommunicativeKindnessSociabilityProblem solvingProactivity

Knowledge

Self Assessment :
Medical devices Phase I R&DBudget ManagementCancerCardiologyClinical monitoringClinical researchClinical operationsClinical trial audits and inspectionsClinical trial managementDermatologyEDCGood Clinical Practice (GCP)Informed Consent DocumentsSupervising CRAsPhase IIIPhase IIPhase IVoncologySerious Adverse Event (SAE)Regulatory submissionsPharmaceutical Industry

Skills and Expertise

Self Assessment :
Monitor a clinical study Interact with physiciansApprove monitoring reportsAttend investigator meetingCollaborate with principal investigatorSupervise clinical monitorsInformed consent process

Training and Certification

  • Barnett International certified: Good Clinical Practices for Clinical Trials in 2011 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
French
Native

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Clinical Project Manager (CPM) Clinical Project Leader Clinical Trial Manager
  • Locations I am interested in:
    Île-de-France, France
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position
  • International:
    No

Area / Region

Paris, France

Others

Driving License
  • Yes