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Summary

Vivienne van de Walle, MD, PhD, CPI, FAPCR studied medicine at the University of Maastricht in the Netherlands and did part of her medical training at the University of Oxford in the UK. During her medical training she enjoyed the combination of patient care and clinical research. She received an additional medical science degree for her research in OBGYN, pediatrics and genetics when she graduated. In 2004 she successfully defended her thesis on Auxology for her PhD. She has always combined clinical research with patient care and has been a full time investigator since 1999 at independent clinical research sites. Vivienne co-founded and has co-owned PT&R, an independent research site, since 2006 and taking full ownership in 2013. In 2011 she passed the CPI exam. She is a member of the national BROK/GCP exam commission, the ACRON, APCR and the VP of the NVFG (Dutch Federation of Pharmaceutical Physicians) and is a member of Leadership Council of the SCRS (Society of Clinical Research Sites). For almost 20 years Vivienne has presented at many companies and conferences on the site’s experience of conducting clinical trials. She has been invited to teach at CROs, Pharma companies and at Universities. She is also often asked as a consultant for CROs, Vendors and pharma companies regarding protocol development, feasibilities, Company - Site relationship and on social media. Before all of this she participated in a clinical trial herself. As a result, Vivienne has a unique perspective of all sides of the table in clinical research. Her full bio and CV can be found on her website: www.vivho.com and is registered in the SIP portal of TransCelerate

Experiences

Current Experience

  • Consultant Ellicott City, MD, United States
    Since March 2016
    Leadership Counsel member

  • Owner
    Since March 2013
    Working under VivMedical

  • (Medical) Director / owner/ Research Physician at an independent research site
    Since January 2004

Past Experience

  • DSMB member
    January 2017 --- January 2018

  • Clinical Research Consultant USA,
    October 2016 --- December 2017

    Consulting on clinical operatons from a Site's perspective for various TransCelerate Workstreams

  • Feasibility / Medical consultant and CRA trainer
    September 2004 --- December 2014

  • Medical Consultant and CRA trainer
    January 2008 --- January 2011

  • Research Physician and Medical Director
    January 1999 --- January 2004

Personality

Self Assessment :
AuthenticityCreative thinkingFlexibilityIndependenceInterest in knowledgeResponsibilityResult OrientedSelf-disciplineSelf-disclosure

Knowledge

Self Assessment :
R&DAllergy and immunologyCardiovascular diseasesBudgetsClinical monitoringClinical researchClinical trial designClinical trial budgetingClinical trialsCoachingCRFCROCTMSCurrent Good Manufacturing Practice (CGMP)Data entryDrug DevelopmentDrug AccountabilityeCRF DiabetesCRF designDermatologyDrug development processEDCEndocrinology and metabolismGeneral MedicineGeneral practiceGenomicsGenetics
LinkedIn Assessment :
Clinical researchGCPClinical trialsHealthcareCROSMOMedicineMedical affairsClinical DevelopmentoncologyPharmaceutical IndustryInfectious diseasesDiabetesCTMSICH-GCPClinical monitoringDrug SafetyPharmacovigilance

Skills and Expertise

Self Assessment :
Adverse event reporting Interpret data Interact with physicians Monitor a clinical study Create SOPs Assure medical quality Build and manage the Trial Master File (TMF) Control data Interact with nurses Technology research Use content management systemsApprove patient informationAssess site feasibilityAssist study siteAssist with site trainingAttend investigator meetingAttend at steering committee meetingsAssure medical qualityAttend steering committeeAttend seminars, courses and meetings within and outside the companyAttend seminarsCoach clinical staffCollaborate with medical teamCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with principal investigatorCollaborate with project teamCommunicate with investigatorCommunicate with sponsorData verificationcoordinating research projectsCoordinationCreate SOPsCreate standard operating procedure (SOP)Design clinical presentationDevelop ICH/GCP compliant processesDevelop study budgetEnsure good clinical practice (GCP)Estimate subject complianceEvaluate protocolsGastrointestinal diseasesGuide staffHandle callsHandle incidentsIdentify and provide training to trial team and associated staffIdentify sitesInformed consent processInitiate clinical trials Interact with computer specialistsInteract with CROsInteract with nursesInteract with pharmacistsInteract with physiciansInteract with pre-clinical scientistsLiaise with doctorsLiaise with doctors and other professionals throughout the studyLiaise with professionals in other divisions of the company as requiredLiaise with research teamLiaise with research team in order to accurately collect and record datalifescienceLogging enrolmentMaintain strong relationshipsManage budgetsManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Manage front deskManage Quality Management System (QMS) documentationManage research projectsmanaging a small teamManuscript reviewNegotiate budget Negotiate payment schedulesNegotiate protocol details NegotiationNetworkOral presentationOversee data collectionParticipate in medical reviewPatient recruitmentPerform routine testsPresent at steering committeePresent clinical resultsPresent data at congressProvide study site fileProvide trainingR&DReport serious adverse events (SAE)Resolves queriesRespond to audit findingsReview clinical study reportsReview exclusion criteriaReview inclusion criteriaReview informed consent processReview protocolsReview queriesSchedule trial visitsScheduling trial visitsScreen patientsSite managementTeach university studentsTeachingTrain off site staffTrain on site staffTrain StaffUnderstand protocolsUpdate Clinical Trials Management System (CTMS) Work collaboratively with the other members of the clinical research team Work cross-functionallyWork under specific instructionsWork with coordination and data management teams

Education

  • FAPCR in Clinical research from APCR in 2017
  • CPI in Clinical Reseach from APCR in 2013
  • Ph.D. in Medicine from Maastricht University in 2004
  • MD in Medicine from Maastricht University in 1999
  • MSc in Medicine from Maastricht University in 1996
  • Trainee in pediatrics and genetics from University of Oxford in 1995

Training and Certification

  • Pharmacovigilance in 2018 Certification
  • FAPCR in 2017 Certification
  • Certified physician in Belgium Certification
  • CPI Certification
  • Design and Interpretation of Clinical Trials Certification
  • Drug Development Certification
  • FAPCR (fellow of the academy of pharmaceutical research physicians) Certification
  • Introduction to Forensic Science Certification
  • Introduction to Pharmacy Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
German
Elementary Proficiency
French
Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    Associate Director Clinical Operations Clinical Development Consultant Clinical Operations Manager Clinical Research Manager Clinical Research Physician Clinical Research Coordinator Clinical Research Consultant Clinical Safety Associate Clinical Trial consultant CRM Doctor Drug Safety Officer Managing Director Medical Advisor Medical Affairs Associate Medical Data Coordinator Medical Director Medical Manager Medical Officer Medical Science Liaison (MSL) Pharmacovigilance Assistant Pharmacovigilance Officer Physician Quality manager R&D manager Regulatory Affairs Assistant Regulatory Affairs Associate Senior Consultant Study Start-up Specialist
  • Locations I am interested in:
    Belgium France Germany Luxembourg Netherlands Switzerland UK USA
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    50% FTE
    BrightOwl freelancer
  • International:
    Yes
  • Availability:
    Feb 2018 : 65%
    Mar 2018 : 65%
    Apr 2018 : 50%
    May 2018 : 50%
    Jun 2018 : 50%
    Jul 2018 : 50%

Publications

    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Netherlands

Others

Driving License
  • No