Certified professional in clinical research, with 4+ years combined experience, in clinical data management (design of the CRF, CDISC, data cleaning, SAE reconciliation, data capture system improvement ) in communication with various stakeholders(clinical team and clinical operation team and on- sites team), in setting timelines and follow-up regularly to ensure delivery of all Data Management milestones and assessment of the performances of the peoples, in organization and leading of regular meetings with the stakeholders, in training and coaching new comers, in providing support to stakeholders and supporting of the IT team for the validation of new applications.
Currently, working as Clinical trials Project Manager responsible for set-up of new tools and processes and implementation of new projects, data cleaning, coding of medical terms, improvement of the existing processes, communication and negotiation with clients, implementation on the time of their requests, resources and performance assessments, planning of the activities, follow up and solving of issues, readiness of the documentation for future audits and inspections.
Since January 2014
· Set up of the clinical data management department (improvement of the processes, writing of the SOPs).
· Management of clinical trial (Cardiology phase II study) in homemade EDC system.
· Improvement of the Homemade EDC.
· Protocol review and implementation.
· Planning of the data management related activities.
· Conception of Edit checks plan and validation after their programmation.
· Creation of variables in e-CRFs and Validation of screens dynamics.
· Writing of Data (Management, Validation, and Review) plan.
· Performing the medical coding (WhoDrug and MedDRA)
· Lab reconciliation
· Patient’s data review
· Communication with the clients.
· Conception of tools allowing the tracking of the completion of the e-CRF and the progression of the cleaning (Visit report and queries status report )
· Readiness of the documentation for future audits and inspections
Lead Medical Data Rewiever Rixensart, Belgium
March 2011 --- January 2014
· Medical monitoring of data.
· Management of 5 others medical data reviewers.
· Planning of resources for the cleaning of data
· Full training of Medical data reviewer based in India.
· Performing of Quality Control of the data.
· Support of the clinical team
· Coordination of data cleaning.
· Participation to pre-analysis meetings and to the preparation to the database lock.
· Organization of meetings with the Clinical team.
· Writing of the cleaning guidelines
· Interaction with the Safety team for the issues regarding the SAEs.
· Interaction with the Global study manager in order to induce the sites to answer to the queries.
· Tracking of the completion of the e-crf.
· Writing of the completion guidelines for the investigators.
. Database freeze for a Final Analysis.
Clinical Data Manager (DM)
September 2009 --- March 2011
· Review of the clinical data(paper CRF )
· Sending of manual queries and automatic queries
. Communication with the CRAs
CollaborationAnalytical thinkingCritical thinkingProblem solvingStrategic thinking
BiochemistryBioinformaticsBiopharmaceuticalsCancerCDISCClinical Data Management (CDM)Clinical monitoringClinical operationsClinical pharmacologyClinical Study DesignData cleaningData ManagementElectronic Data Capture (EDC) oncologyPharmaceutical IndustrypharmacologyPhase IIPhase IIIPhases of clinical development (phase I to IV)SOPWriting Study Procedures and SOPsPowerPointGCP
Skills and Expertise
Create SOPs Control data Assure medical quality Interact with physicians Monitor a clinical studyApprove queriesApprove patient informationCalculate trial timelinesClinical data collectionCommunicate with investigatorCommunicate with sponsorComplete case report form (CRF)Complete study proceduresCreate SOPsData codingData entryData verificationDesign case record form (CRF)Data validationOrganise meetingsOral presentationProvide trainingQuality control processReview queries
MASTER in Pharmacochemistry-Pharmacology- Chemistry from Université de Nantes in 2007
Training and Certification
Clinical research Associate Junior in 2009 Certification
Expert has 1 publications (Will be avalible with full profile)