BrightOwl Loader Loading


Dorothee Uriet - 29/10/1977                                                                                         

51 Bis rue Bokanowski                                                                                                        Mobile: +33(0)6 95 98 32 27

92600 Asnières-sur-Seine







  • 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)






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

  • Nutrition and Immune system Activities: International clinical project manager of a plan of 5 studies

Tasks:Coordination of a multipluridisciplinary team: CRO, RA, Biometry, Production, Analytical Support…

Writing of the study documents (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

  • Pneumology, Addictology, Obstetrics gynecology

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 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

  • Rheumatology - CRA on Phase II study
  • Cardiology – CRA on 2 studies, 1 Phase III and 1 phase IIIb

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

  • Endocrinology, Nephrology

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

  • Product manager in the molecular biology line including


Sept 2001 - June 2003, technical support engineer, ABCSYS, Paris

  • Manager of the technical department in a distributor of laboratory reagents coming from biotechnologies






One day training «  Vigilance of IS and pharmacovigilance NIS at a European level (Sunnikan, Paris)


One day training on the French Bertrand Law and unique hospital agreement (Delsol consultant, Paris)


Orphan Drug Seminar (Eudipharm, F-CRIN et OrphanDev, Marseille)


DIA Clinical forum conferences (DIA, Dublin)


Sales certification training (Cegos - Paris)


GCP and quality in clinical trials - Jardé - Audit and Inspection (For Drug Consulting)


European regulations applied to medical devices, 1 day (IFIS - Paris)


Commercial negotiation: 6 winning stages, 3 days 2(CEGOS - Paris)


Good Clinical Practices applied to Data Management, 1 day (KBP-Levallois-Perret)


New environment of the biomedical research, 1 day (For Drug Consulting - Levallois-Perret)


Project management in Clinical Research, 3 days (Metanaction - Paris)


Pharmacovigilance, 3 days (For Drug Consulting - Paris)


Statistical methodology in Tobacco addiction clinical trials, 2 days (SRNT - Prague)


Quality assurance training, 5 days (CEGOS - Paris)


Industrial Property and Management of risks and the Quality, ESABIO, 1 days/weeks during 6 months (Leonard de Vinci institute - Courbevoie)


Selling advices training, 5 days (Techsas formation - Reims)






CESAM diploma of Biostatistics applied to clinical trials (5 Hrs/Week/6 months) (University Pierre et Marie Curie - Paris VII) (13.5/20)


Diploma of Clinical Research Associate - (Clinact – Paris)


Post-graduate in Cellular engineering and therapeutic strategies - PharmaBiotech (Pharmacy University of Reims)


First two years of BSc, Bachelor degree, Master degree in Biochemistry - (Sciences University of Reims)


First year of medicine school (Medicine school of Reims)



Current Experience

  • Global Clinical Project Manager (GCPM, GTM)
    Since March 2008
    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


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


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


  • 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


BrightOwl Assessment:
Self Assessment:
Full Proficiency
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:

Area / Region

Levallois-Perret, France


Driving License
  • Yes