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Summary

Experience in Phase I to phase IV international studies.


Therapeutic experience


Project Management (Phase I to III)

Digestive System : Antibiotic-Associated Diarrhoea, H. pylori and Enterotoxigenic E. coli infection
Cardiology : Acute Coronary Syndrome
Endocrine/Metabolic : Down’s syndrome (paediatric)
Haematology/Oncology : Acute Lymphoblastic Leukaemia
Neurology : Alzheimer’s Disease
Odontology : Root Canal Sealing
Ophthalmology : IOL Start-up
 

Start-up (Phase II to III)

Dermatology/Oncology : Stage IV Melanoma
Endocrine/Metabolic : Diabetes, Obesity
Infectious : HIV, Influenza (paediatric)
Inflammatory : AA Amyloidosis
Neurology : Chronic Inflammatory Demyelinating Polyneuropathy, RRMS
Ophtalmology : Central Retinal Vein Occlusion
Oncology : Prostate cancer
Pulmonology : Severe Asthma Monitoring


Monitoring (Phase II to IV)

Dermatology : Atopic Dermatitis
Digestive System : Crohn’s Disease
Haematology/Oncology : Relapsed Chronic Lymphocytic Leukaemia
Endocrine/Metabolic : Diabetes, Obesity

Experiences

Current Experience

  • R&D Clinical Project Manager Palaiseau, France
    Since November 2015

Past Experience

  • R&D Clinical Project Manager at Aixial (Danone Research)
    January 2014 --- October 2015

    - Accountable for the proper conduct and delivery of the clinical projects - Leads the internal and external coordination of international clinical projects, from their concept until the exploitation of the results, with respect to international guidelines and local regulations - Takes part, in close collaboration with Scientists and Medical Direction, to the definition of the Health Brands studies plans, and recommends the best study design to perform, assuring the conformity with methodology and ethical aspects versus business strategy - Coordinates and participates to the design and validation of the project documentation, including risk management - Defines and analyses the budget and the planning of the studies, taking business, science & methodology constraints into account - External tender review and budget/contracts negotiation

  • Clincal Project Manager
    June 2012 --- January 2014
    - Managed research team participating in multiple clinical studies (regulatory activities, contracts implementation, communication with partners and clinical investigators, training and management of monitors and research team, preparation of study-specifc documents and study files) according to study budget - Managed the development and customisation of clinical tools (eCRF, IVRS and CTMS) according to sponsors' requirements - Coordinated activities for different start-up and feasibility programs in different therapeutical areas (Oncology, Neurology, Cardiology, Ophthalmology, Odontology, Paediatric) - Reviewed and approved monitoring visit reports - Reviewed and finalised study protocols - Prepared and attended audits - Attended business development meetings and prepared budget proposal to new partners and answer to RFPs

  • Senior Start-up Clinical Research Associate
    October 2010 --- June 2012
    - Performed and coordinated the identification and selection of qualified study investigative sites, conducted site evaluation visits in accordance with ICH-Good Clinical Practices, FDA guidelines and global Standard Operating Procedures to ensure the selection of appropriately qualified sites in France, Switzerland and Germany - Represented PPD in the global medical research community and developed collaborative relationships with investigative sites - Supported local Clinical Management in the mentorship, training and work direction of local start-up team members. Identified and suggested potential process improvements. Provided feedback on tools, processes and procedures. Acted as a point of reference for operational and role-specific questions - Assisted in the regulatory submission activities as well as contracts negociation with investigative sites

  • Senior Clinical Research Associate (CRA)
    January 2010 --- October 2010
    - Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products - Conducted Evaluation, Initiation, Interim Monitoring, Close-out, and Motivational visits in France, Switzerland and Germany for phase II and phase III studies - Mentoring of new employees (conducted accompanied field visits) - Presented at investigator meetings - Management of advertisement in local newspaper to improve patient recruitment

  • Clinical Research Associate (CRA)
    September 2007 --- October 2010
    Conducted Evaluation, Initiation, Monitoring and Close-out visits at investigative sites in France, Germany and Switzerland.

  • Clinical Research Technician
    September 2006 --- August 2007
    - Performed exam collection, quality control and data management of medical images - Prepared the database for safety/comparative central reading sessions - Generated and resolved data clarification forms with investigators and radiologists in case of discrepancy in database - Reviewed and authorised the participation of radiology sites in clinical studies - Contacted the investigative sites to provide the safety review result for each patient.

Knowledge

LinkedIn Assessment :
Clinical monitoringCROClinical researchFluent EnglishProject ManagementRegulatory RequirementsmanagementMentoringPharmaceutical IndustryStaff TrainingDrug DevelopmentMedical EthicsPharmaceuticalsbid-defenseBudget ForecastsInternal AuditStart-up OperationsICH-GCPFood IndustryClinical DevelopmentCTMSClinical trialsProtocolGCP

Education

  • in from in 2004

Training and Certification

  • Clinical Research Associate Foundation Course (PPD Cambridge UK) in 2007 Training
  • Languages

    BrightOwl Assessment:
    Self Assessment:
    French
    Native
    English
    Full Proficiency
    German
    Professional Proficiency

Area / Region

Paris, France

Others

Driving License
  • Yes