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Summary

Position in clinical operations: • Global Data Manager in Oncology. • CRA in Cardiology, Epilepsy, Vaccines and Oncology. Position in System Analysis and IT solutions: • Computer Technician Specialties: CRA • Monitoring activities following GCP • Design, development, validation and full cleaning of CRFs • Experience of cold chain maintenance Data Manager • Supporting set-up and maintenance of database (DM, safety, clinical) • Control of project performance (quality, objectives and timelines) • Design, review and adaptation of Case Report Forms (CRF) • Use ICD-10, RECIST 1.1, MedDRA , CTCAE v 4 and WHO-ART Dictionaries • Serious Adverse Events (SAE) Reconciliation • Knowledge of CDISC (CDASH/SDTM) • Knowledge of SAS applications System Analysis and IT solutions • Reparation of OS (Windows, Linux and Mac) • Installation of software for medical devices and medical instruments

Experiences

Current Experience

  • Clinical Data Manager (DM)
    Since September 2012
    ≡ Discrepancy management of clinical data in CRF with Oracle RDC: - Review incoming data, - Generate, review and close queries, - Study Coordinator at site cooperation for CRF completion - CDISC (CDASH/SDTM) knowledge ≡ Liaise with Study Coordinator and CRA at Sponsor: - highlight issues and suggest solutions, - prevent potential quality/safety issues, - follow up of ongoing queries and case discussions - ensure CAPA . ≡ Production of listing and reports ≡ Reconciliation process for Serious Adverse Event (SAE) and safety cases.

Past Experience

  • Data Manager
    July 2012 --- July 2012
    Finalization of Clinical Study Report: -Editing and coding of data -Summary tables as per ICH E3

  • DM and CRA
    April 2009 --- April 2012
    DATA MANAGER Data Entry for clinical trial phase IV Design of Case Report Forms with Pheedit software Data management of clinical trials of phase II and III Writing validation rules for EDC and CRF studies Maintain study documents in accordance with departmental SOP's Used ICD-10, RECIST 1.1 and WHO-ART Dictionary for coding Concomitant Medications and Collaborating with Medical, Clinical, Biostatistics and Drug Safety Other duties as assigned by management

  • DATA MANAGER
    April 2007 --- March 2009
    Bioinformatician Data management of Microarray data Gene Signaling Pathway Analysis and Representation Tools and methods to integrate pathway information and high throughput data Tools and methods for the representation of pathways Visualization of pathways

  • Clinical Research Associate (CRA)
    October 2007 --- April 2008
    Monitoring (initiation and routine visit) investigator sites for GCP compliance according to SOPs Coordinating and partecipating to Investigators' Meetings Study supplies (study documents, radioactive material and medicinal product) Knowledge of cold chain mantainance

  • Computer Technician
    December 2006 --- October 2007
    Informatics Specialist: Repair and assembly Hardware for PC Repair OS from viruses and software for medical devices Create and manage private network

  • Study Manager
    July 2005 --- December 2006
    Data Entry for clinical trial phase II-III Reviewed case report forms (CRF) data of a patient enrolled in a protocol Reviewed CRFs to identify erroneous, incomplete, or implausible data Maintained study documents in accordance with departmental SOP's Serious Adverse Events Reconciliation Worked with Medical and CRA to resolve discrepancies pertaining to data in the clinical database Solve data clarification forms (DCFs) or on-site DCFs for sponsor Assisted with QC audits by reviewing key data listings vs CRFs and documenting data problems in QC spreadsheet Used ICD-9, RECIST 1.0 for coding Concomitant Medications and Adverse Events

  • Clinical Research Associate (CRA)
    October 2004 --- December 2006
    Monitor (routine visits) investigator sites for GCP compliance according to SOPs and/or client guidelines Obtain, review, and process regulatory and administrative documents from investigator sites Coordinate and present at Investigators' Meetings Participate in proposal meetings with vendors Prepare project management reports for project personnel, and upper management Resolve issues, questions, and requests for clinical sites Study supplies (study documents, material and study drug) Producing monitoring reports Assisiting study site personnel on data queries solution of CRF *Document and clinical material management. *Patient recruitment verification and initiatives

  • Biomolecular Cardiopharmacology Researcher
    September 2001 --- December 2004
    I worked in a European project for discovering the connection between If channel re-expression in patient with Atrial Fibrillation or Heart Failure. I acquired expertise in using Real time PCR to correlate the gene expression with electrophysiological data of patch clamp of cardiomyocites.

Knowledge

Self Assessment :
SAS
LinkedIn Assessment :
Clinical trialsGCPClinical researchData ManagementPharmacovigilanceDatabasesMicrosoft OfficeElectronic Data Capture (EDC) Database AdministrationOracle ClinicalCDISCVaccinesMicrosoft ExcelMicrosoft WordSOPGraphic DesignAdobe Creative SuitePhotographyoncologyMedDRAInformatic TechnicianFast LearnerGuitaristCookingTravelComicsExcelWordCDASHCRF designSommelierWine TastingSAS programmingCROSOP

Education

  • MD in Biology from Università degli Studi di Firenze in 2000
  • in from SAS Institute in 0

Training and Certification

  • SAS ENTERPRISE I in 2014 Training
  • SAS PROGRAMMING I in 2014 Training

Area / Region

Brussels, Belgium

Others

Driving License
  • Yes