BrightOwl Loader Loading

Experiences

Current Experience

  • Founder and Principal Consultant
    Since January 2015

Past Experience

  • Director, Data Management & Bio Statistics
    March 2012 --- November 2014

  • Group Manager, Data Management & Bio Statistics
    June 2009 --- February 2012

  • Senior Data Manager
    January 2008 --- May 2009

  • Technical Data Manager
    December 2002 --- December 2007

  • Software Consultant
    January 2001 --- November 2002

  • Systems Analyst
    January 2000 --- January 2001

Personality

Self Assessment :
AdaptabilityAnalytical thinkingAttention to detailCharmCollaborationCommunicativeCompetitivenessCreative thinkingResult OrientedSociabilityStrategic thinking

Knowledge

Self Assessment :
Biostatistics Diabetes Medical devices Negotiation Phase I R&DAccount ManagementAnalytical techniquesBioinformaticsBudget ManagementBudget NegotiationBudget ProcessCDISCClinical Data ManagementClinical Data Management (CDM)Clinical trial audits and inspectionsContract negotiationDatabase design and maintenanceEDCElectronic Data Capture (EDC) EnglishFDAGCPGood Clinical Practice (GCP)ICH GCP guidelinesOutcome Measurement Study (OMS) Patient Reported Outcome Measures (PROMs)people managementProgrammingProject ManagementQuality of Life (QoL) outcomesSOPTechnology transferValidationWriting Study Procedures and SOPs
LinkedIn Assessment :
CROPharmaceuticalsClinical trialsClinical trial managementClinical researchClinical Data ManagementBiostatisticsBusiness ManagementSOPSOPmanagementGCPData ManagementPharmaceutical IndustryCTMSEDCICH-GCPClinical Development

Skills and Expertise

Self Assessment :
Create SOPs Design case record forms Build and manage the Trial Master File (TMF) Control data Report data Technology researchData validationDesign case record form (CRF)Design data collection systemsDesign database Design data reporting systemsDesign study documentsManage data collection systemManage data reporting systemsSerious Adverse Event (SAE) Reconciliation

Education

  • MCA in Masters in Computer Applications from University of Kerala in 1999
  • B Sc in Physics from University of Kerala in 1996

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Swedish
Professional Proficiency

Area / Region

Stockholm, Sweden

Others

Driving License
  • Yes