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Summary

dorothee uriet - 29/10/1977                                                                                                   dorotheeuriet@gmail.com

51 bis rue bokanowski                                                                                                        mobile: +33(0)6 95 98 32 27

92600 asnières-sur-seine

29/10/1977

 

 

skills

 

 

  • skills : deep knowledge clinical and epidemiological research (institution, pharma industry, CRO, biotech companies)
  • it skills : office package, data base (filemaker, act), CTMS, eCRF, risk based monitoring
  • languages : French: native language, English (fluent), spanish (intermediate)

 

professional experience

 

 

 

from march 2008 ongoing, keyrus biopharma CRO, levallois-perret

from december 2013 - ongoing, international Project Manager

  • oncology (mrcc)– real life study (10 european countries, 200 sites, 750 patients), currently in recruitment phase

management of a multidisciplinary team (1 ctc, an average of 8 cras, 1 dm, 1 bst, 1 sp, mw, 2 raa)

eCRF development and regulatory submissions management in every involved countries

management of contract adaptation in all countries and in all centers (when appropriate)

full management of the project (timelines, quality and budget follow-up and reporting)

  • Endocrinology (acromegaly)- a local observational study involving physicians and study nurses

management of investigators fees and budget fence (replacement of a maternity leave)

  • oncology (pancreatic neuroendocrine tumors)- observational study requested by the French has and sponsored by two pharma companies

involving management of a clinical of 1 ctc and 4 cras within the multidisciplinary team

  • oncology (esophagi-stomach junction Cancer) – close-out phase of a French observational study involving clinicians and central labs and reviewers Lab.

check of the samples dispatch to the central Lab and to the Reviewer labs and budget reconciliation

  • rheumatoid arthritis – study “soins courants”, 30 sites, 150 patients, 3 cras, multidisciplinary team

 

from june 2010 to december 2013, Account Manager / Business Developer / Outsourcing manager

business activities: Sales, management, technical knowledge, Scientific writing skills

management of a client’s portfolio (15 clients + numerous prospects)

management of 15 outsourced clinical Project Manager and Regulatory Affairs consultants (recruitment, follow-up)

animation and management of the Medical Devices offer (regulatory framework and Market Analysis)

proposal manager: writing of the request for information and request for quotation for every quotations

organization, preparation and participation in bid defense meeting

initiation and follow-up of customer agreements and Budgets

 

from march 2008 to may 2010, clinical Project Manager, CRO internal

  • hemostasis - epidemiological study from the selection to the close out phase
  • ophtalmology - a Phase I clinical project from the submission to the recruitment

tasks: project team management and budget and p&l management, reporting to the sponsors

 

clinical Project Manager, outsourced

tasks:coordination of a multipluridisciplinary team: CRO, ra, biometry, production, analytical support…

writing of the study documents (science)" >Protocol, icf, crf)

request for proposal management and oversight of cros

organization and participation in the kick off meeting

 

from january 2005 to february 2008, Clinical Research Coordinator, at ap-hp and inserm (psl Hospital), paris

tasks: coordinator on 2 clinical studies (iiib phase) and 1 physiopathological study (on newborns and mothers)

selection and management of providers: transporters, suppliers of materials, equipments, central Laboratory

development of electronic case report form, writing of the science)" >Protocol with the principal Investigator

feasibility study and selection of participating centers

administrative follow-up: Validation of financial contracts, Hospital agreements, ptcs and investigators fees

organization of investigators meeting before and during the study (motivation)

management of junior cras: co-monitoring and review of monitoring reports

budget management

 

from may 2004 to january 2005, Clinical Research Associate (CRA), novartis pharma, rueil-malmaison

tasks; selection, initiation (sites and local laboratories), monitoring, close-out visits

managements of the queries, follow-up of the serious Adverse Events, the update of the CTMS and study boeards (administrative, statutory, saes, recruitment, monitoring)

animation to grouped Investigator meetings

collaboration with multidisciplinary team

 

february 2004 to april 2004, Clinical Research Associate, clinact CRO, sevres

tasks; CRA on Phase IV and cohorts studies

Investigator selection and scientific initiation visits by phone

centralized monitoring activities

 

june 2003 - january 2004, Product Manager, miltenyi biotech, paris

 

sept 2001 - june 2003, Technical Support Engineer, abcsys, paris

 

Training

 

 

2015

one day Training «  vigilance of is and Pharmacovigilance nis at a european level (sunnikan, paris)

2014

one day Training on the French bertrand law and unique Hospital agreement (delsol Consultant, paris)

2013

orphan drug seminar (eudipharm, f-crin et orphandev, marseille)

2013

dia clinical forum conferences (dia, dublin)

2012

Sales certification Training (cegos - paris)

2012

gcp and quality in Clinical trials - jardé - audit and inspection (for drug Consulting)

2011

european regulations applied to Medical Devices, 1 day (ifis - paris)

2010

commercial Negotiation: 6 winning stages, 3 days 2(cegos - paris)

2009

good clinical practices applied to Data Management, 1 day (kbp-levallois-perret)

2008

new environment of the Biomedical research, 1 day (for drug Consulting - levallois-perret)

2008

Project Management in clinical research, 3 days (metanaction - paris)

2007

Pharmacovigilance, 3 days (for drug Consulting - paris)

2006

Statistical methodology in tobacco addiction Clinical trials, 2 days (srnt - prague)

2001

Quality Assurance Training, 5 days (cegos - paris)

2001

industrial property and management of risks and the quality, esabio, 1 days/weeks during 6 months (leonard de vinci institute - courbevoie)

2000

Selling advices Training, 5 days (techsas formation - reims)

 

Education

 

 

2007

cesam diploma of Biostatistics applied to Clinical trials (5 hrs/week/6 months) (University pierre et marie curie - paris vii) (13.5/20)

2004

diploma of Clinical Research Associate - (clinact – paris)

2001

post-graduate in cellular Engineering and therapeutic strategies - pharmabiotech (Pharmacy University of reims)

1997-2001

first two years of bsc, bachelor degree, master degree in Biochemistry - (Sciences University of reims)

1995-97

first year of Medicine school (Medicine school of reims)

 

Experiences

Current Experience

  • Global Clinical Project Manager (GCPM, GTM)


    Since March 2008
    international Clinical Project Manager therapeutics area: oncology, Rheumatology, phases: iv, "soins courants" International Clinical Project Manager Therapeutics area: Oncology, Rheumatology, Phases: IV, "soins courants"

Past Experience

  • Clinical Development Manager and international business developer

    June 2010 --- December 2013
    in charge of Clinical consultants outsourced rfp unit Coordinator Business Developer in charge of Medical Devices offre

  • International Clinical project manager for Danone

    April 2008 --- September 2008
    - coordination d’études cliniques sur volontaires sains dans le domaine de la Nutrition - plan de développement clinique de 5 études (5000 sujets) : calendrier, devis, faisabilité du projet, analyse de risque, choix des prestataires, collaboration à l’écriture du protocole et autres documents… - coordination de la contribution au projet des intervenants suivants : CRO de monitoring, ingénieur d’étude des brand team, service juridiques, département biométrie, production, support analytique et sécurité des aliments. - Leader de groupes de travails concernant des activités transverses telles que la recherche et la Validation de questionnaires de qualité de vie ou bien le recensement des documents de référence relatifs à l’activité coordination clinique

  • Clinical Research Coordinator

    February 2005 --- February 2008
    - coordination et monitoring de trois études cliniques (Phase III, iv et physiopathologique) dans le domaine de l’addictologie (tabac), au sein de populations de patients à hauts risques et de femmes enceintes, en milieu hospitalier. - gestion de la totalité des centres soit environ 15 centres (france entière). - elaboration des Budgets des études, choix des prestataires, organisation des circuits logistiques (Biologie, documents, etc.) missions transversales: - formation des nouveaux arrivants et management d’une petite équipe de travail - référente assurance qualité pour l’unité auprès de la direction de la recherche clinique ile-de-france

  • Clinical Research Associate (CRA)

    June 2004 --- January 2005
    visites d’initialisation, de monitoring et de clôture, dans le cadre d’études de Phase II en cardiologie et de Phase III en rhumatologie pratique du crf électronique (par edc via phosco), résolutions de queries et interface entre utilisateurs et support en angleterre collaboration avec les réseaux de médecins généralistes / monitoring centralisé avec study Nurse

  • Clinical Research Associate Trainee

    February 2004 --- April 2004

  • Product manager molecular biology

    June 2003 --- January 2004

  • consulting engineer

    September 2001 --- June 2003

Personality

Self Assessment :
Willingness to compromiseSelf-disciplineProblem solvingProactivityOrganizationStrategic thinkingResult OrientedInterest in knowledgeCritical thinkingCommunicative

Knowledge

LinkedIn Assessment :
Medical DevicesBiotechnologyNutritionPharmaceutical IndustryRegulatory affairsMedical writingData ManagementSystem MonitoringClinical trialsObservational studiesCROCTMSClinical DevelopmentGCPClinical researchEDConcologyLife SciencesICH-GCP

Skills and Expertise

Self Assessment :
Written presentationWriting regulatory documentsUnderstand protocolsTrain on site staffSupervise trial suppliesSupervise clinical monitorsStudy-related documentsStudy execution planSolve problemsSite managementSet up a clinical studySerious Adverse Event (SAE) ReconciliationSelect investigatorsSelect contractors Review study protocolsReview queriesReview protocolsReview monitoring reportsRetrieve study documentsResolves queriesReport serious adverse events (SAE)Report non-compliance incidentsRegulatory submissionsProvide study site fileProvide medical rationale of diseasePresent data at congressPlanning clinical studiesPersuade clinicians to conduct clinical trialsOrganise meetingsOral presentationNegotiationNegotiate payment schedulesNegotiate budget Monitor clinical trials managing a small teamManage study supplyManage subject consent formManage data reporting systemsManage Clinical Trial Management System (CTMS) Manage contractors Manage clinical trial files/documentsLiaise with doctorsInteract with physiciansInteract with nursesInteract with pharmacistsInitiation visitInformed consent processInteract with CROsIndentify sitesIdentify investigatorsEthics committee submissionsEstablish contractsEnsure good clinical practice (GCP)Estimate subject complianceEnsure data integrityEnsure data consistencyDevelop study timelinesDevelop study metricsDesign trial master file (TMF)Design subject consent formDesign study documentsDesign clinical presentationCreates a collaborative team environmentCoordinate logisticsConduct the trialConduct site initiationConduct post-marketing surveillance studyConduct monitor visitsCommunicate with investigatorCollect financial data from hospitalsCollaborate with project teamCoach staffCollaborate with medical teamCollaborate with principal investigatorCalculate trial timelinesBuild trial master file (TMF)Attend investigator meetingAssess site feasibilityArchive study documentsApprove monitoring reports Write papers Monitor a clinical study Create SOPs

Education

  • Bac+5 in Biostatistics from Université Pierre et Marie Curie (Paris VI) in 2008
  • Dess pharma biotech in Health from Clinact CRA training in 2005
  • Bac+5 in Biotechnology from ESABIO Institut Léonard de Vinci in 2001
  • DESS in Biotechnology and pharmacy from Université de Reims Champagne-Ardenne in 2001

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency
Spanish
Elementary Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Positions I am interested in:
    Clinical Project Manager (CPM) Clinical Project Leader Clinical Operations Manager Clinical Trial Manager
  • Work From Home:
    Yes, 1 to 2 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Levallois-Perret, France

Others

Driving License
  • Yes

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