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[QUOTE=dhaha001;252681]Harsha Dhananjaya harsha07aug AT gmail.com [B]OBJECTIVE [/B]: To work in a professional and challenging environment, where I can best apply my knowledge and skills for the betterment and benefit of the organization, achieve organizational and personal goals. [B]WORK EXPERIENCE [/B]: [B]ICON Central Laboratories [/B]: [B]Duration [/B]: 5th January 2009 26th October 2012 [B]Job Designation [/B]: Configuration and QC Specialist II (Apr 2011 Oct 2012) [B]Job Description [/B]: To Support the Project Management Team (PM) in configuring and QC'ing new studies in all ICL systems according to the specifications of the Client Laboratory Worksheet (CLW) and create all supporting documents and site instructions to facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables and study specific Lab Manuals. ** Work closely with PM team in interpreting the CLW specs and ensuring that all is clear and accurate enough for proper configuration into all systems, seeking guidance on any parameters that need clarification. ** Provide PM with configuration support by entering selected elements of the study's specifications into the ICL (ICON Central Laboratories) systems. ** Support PM in the creation of all configuration related forms. ** Updating Lab Manuals or requisition templates as needed. ** Perform new study configuration quality checks on database and document updates ** Configuring Custom manifest and Mapping codes for Storage Sample management. ** Sample tracking and Chronological Data set-up into ICON database. Setting up storage services into LIMS (Laboratory Information Management System) ** Entering Third party lab address for the shipment of Store-out samples. ** Configuring, Uploading and Assigning Third party labels (Barcode) for specific Sponsors. ** Training and mentoring new hires. [B]Job Designation [/B]: Client Service Support & Protocol Site Entry, (Sep 2010 Mar 2011) [B]Job Description [/B]: ** Trouble shooting on day-to-day basis for maintaining the clean data of the study. ** Creation and maintaining client service database such as study assignment list for use of PM complexity models. ** Data entry and quality control review into all systems for all new and updated investigator site listings for new and ongoing studies. ** Queue and process all hard copy lab reports, plus review and monitoring of error logs for all modes of lab report creation and delivery. ** Provide mass faxing and mass emailing services for site and CRA communication such as Quarterly site newsletter, Site memos, announcements and newsflashes, as well as Study-Specific memos as requested by Project Management. ** Troubleshoot, correct and re-queue as needed for the successful delivery of lab results to sites, CRAs and Sponsors. [B]Job Designation [/B]: Medical Technologist II (Infectious Diseases Lab), (Nov 2009 Aug 2010) [B]Job Description [/B]: ** Analysis and Reporting of Microbiology specimens ** Culture and identification of pathological bacteria and parasites. ** Proficiency testing with 100 percent results in CAP (College of American Pathologist). [B] Job Designation [/B]: Accessioner and Data Quality Controller, (Jan 2009 Oct 2009) [B]Job Description [/B]: ** Accessioning and receiving study specimen into LIMS. ** QC of Requisition forms ** Handling Specimen Logistics Gland Chemicals Pvt Ltd [B]Duration [/B]: Apr 2007 to Jun 2008 [B]Job Designation [/B]: Quality Control Chemist [B]Job Description [/B]: ** Analysis of Raw materials, Intermediates and finished products. ** Daily calibration and maintains of Laboratory instruments. ** Preparation and Standardization of Volumetric Reagents. ** Maintains Proper Documentation (SOPs) associated with the preparation and review of analytical specifications, standard testing procedure and other documentation compliance with GLP. ** Records test results on standardized forms and writes test reports describing procedures used. ** Conducts approval / rejection of finished products, Raw materials & In-process samples. [B]EDUCATION QUALIFICATION [/B]: Post Graduate Diploma in Clinical research and Clinical Data Management from Institute of Computational Biology, Bangalore 2004-06 : M.Sc. Microbiology from Oxford College of Science, Bangalore 2001-04 : B.Sc. Microbiology from Government Science College, Bangalore [B]AWARDS and APPRECIATION [/B]: Won performance award ICO 100 at ICON [B]COMPUTER PROFICIENCY [/B]: [B]Basics, MS- Office [/B]: - Word, Excel, Power Point, Access Internet Working experience on LIMS and PACS (Protocol Administration Computer System). [B]SKILL SETS IN CLINICAL RESEARCH DOMAIN [/B]: ** Good understanding of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, Standard Operating procedures (SOPs). ** Knowledge of Medical Terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG) ** Comprehensive understanding of clinical drug development process [B]HOBBIES and INTEREST [/B]: Reading books Listening to music Gardening Play Writing [B]CORE COMPETENCE [/B]: ** Excellent communication, interpersonal, customer service, and teamwork skills ** Excellent organizational and problem-solving skills ** Knowledge of operating procedures and work instructions and the ability to apply them in practice ** Ability to work with minimal supervision, using available resources, ** Ability to establish and maintain effective working relationships with coworkers, managers and customers ** Good Communication skills and leadership qualities. ** Capable of multi tasking and taking on additional responsibilities. [B]PERSONAL DETAILS [/B]: [B]Date of Birth [/B]: 07 August 1983 [B]Sex [/B]: Male [B]Marital status [/B]: Single [B]Languages Known [/B]: English , Hindi , Kannada [B]DECLARATION [/B]: I hereby declare that the information furnished above is true to the best of my knowledge. [B]Place [/B]: Bangalore [B]Date [/B]: (Harsha.D)[/QUOTE]
