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Summary

Consultant Freelance Senior CRA / Clinical Project Manager clinical trials and late phase / Study start up associate/Clinical Development Manager (Feasability, Site selections, Training of the study team) --​> Management of national and international ( Belgium - Switzerland - France ) clinical trials (Phase I to IV). Preparation and clinical trial submission to IEC and regulatory authorities (ANSM, CNO, CNIL ...). Management of essential documents / Monitoring (feasibility, pre study, site initiation visit, monitoring and close out visit) Optimum clinical research (personal company), France --​> Provide Nurses newt work in France, Belgium and Switzerland. African countries and application to enter data directly in eCRF. --​> Seminars/Course Work: - June 2015 : Last update of the applicable regulatory requirements (GCP), of the ICH/GCP and Qualification for the Auditor's job. --​> Therapeutic experience : Oncology: HE2R positif Best cancer, Solid tumor Phase II/III and I/II, Small cell lung phase II Cardiology (Heart valve disease phase III (Medical Device), Acute coronary syndrome phase IIIChronic heart failure phase II, Coronary artery stenosis phase III, Blood high pressure phase III, Hypercholesterolemia phase III CNS: Bipolar troubles phase II, Depression phase III; MD episode children and adolescent phase III Diabetology:Neuripathic pain in diabetics patients phase III Dermatology:Acnea phase IV , Psoriasis phase III Endocrinology:Diabetes phase III, Thyroid phase III Hematology Phase : Non hodgkin’s lymphoma Phase I, Leukaemia Phase I Infectiology :HIV/AID Phase II Neurology: Stroke Phase III, Brain injury phase III Nutrition: Bed stores Phase III, Oncology,Solid tumor Phase II , Small cell lung phase II Ophthalmology: Glaucoma Phase III Pneumology COPD Phase III, Asthma phase IV Specialisations : Propose best solutions to manage efficiency clinical trials. Solutions to improve quality in management of clinical trials.

Experiences

Current Experience

  • Consultant
    Since July 2009

Past Experience

  • Maghreb Team Project Manager
    May 2004 --- June 2009

  • Project Manager
    May 2002 --- May 2004

  • Coordinator CRA
    May 2001 --- May 2002

  • Clinical Research Associate (CRA)
    January 2000 --- May 2001

Personality

Self Assessment :
AdaptabilityAttention to detailAuthenticityCommunicativeCritical thinkingCuriosityEfficiencyFlexibilityInterest in knowledgeProactivityProblem solvingStrategic thinking

Knowledge

Self Assessment :
Biochemistry Diabetes Phase IBudget ManagementBudget NegotiationBusiness PlanningCancer ResearchCAPACardiologyChemistryClinical monitoringClinical operations
LinkedIn Assessment :
Clinical monitoringRegulatory submissionsNorth AfricaEntrepreneurshipEssais cliniquesBonnes pratiques cliniquesOncologieSecteur pharmaceutiqueRecherche cliniqueDéveloppement cliniqueCRODispositif médicalCardiologieNeurologieClinical trials

Skills and Expertise

Self Assessment :
Create SOPs Interact with nurses Interact with physicians Monitor a clinical studyAct as the main line of communication between the sponsor and the investigator

Education

  • DEA in Sciences des Agroressources from Ecole supérieure de Chimie organique et minérale in 1999
  • Advanced Master in Biochemistry from National school of Chemistry Toulouse in 1998

Languages

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

Work Preferences

  • Notice Period:
    1 week
  • Positions I am interested in:
    Project Manager
  • Work From Home:
    Yes, 1 Days
  • Work Regime:
    Permanent position :    80% FTE
    BrightOwl freelancer :    35 Hours per week :    0.8 Free Per Month(in coming months)
  • International:
    Yes

Area / Region

Paris, France

Others

Driving License
  • Yes