Professionalism, efficiency, quality of performance, sense of responsibility

Professional Experience
• Worked as Clinical Data Co-ordinator with Quintiles India Pvt Ltd, Bangalore, from June 2010 to Till Date.
• Worked as Asst. Clinical Data Associate with Icon Clinical Research India Pvt Ltd, Chennai, from September 2007 to March 2010.
• Worked as Research Assistant at Central Food Technological Research Institute (CFTRI)’, Mysore from December 2005 to February 2007.

Clinical Data Management Experiences

? Identification and resolution of data discrepancies
? DCF creation and updates
? Edit check specifications and UAT
? CRF review and design
? Quality review
? Dataset validation
? Creation and maintenance of study files
? RAVE DDE
? Identification and Management of Clinical Trial Issues and Protocol Deviations
? Unblinded data management
? eCRF locking
? External data review ( Lab review, IVRS Review, PK Review, ECG Review etc)
? SAE reconciliation and DURF management
? Interim/Final Database lock
? Study start up-conduct –close out experiences

Therapeutic Areas included:

? Central Nervous System
? Cancer related Pain: Phase 2b
? schizophrenia : Phase III
? Major Depressive disorder: phase III study
? Multiple Sclerosis: Phase II
? Cardio- vascular system
? Arterial hypertension: phase II study
? Women’s health
? Contraception: Phase III study
? Endocrinology
? Ulcerative colitis Phase II
? Diabetes Mellitus-PhaseIII
? Musculo skeletal
? Rheumatoid arthritis Phase I
? Oncology
? Tumour finding
? Gastro-Intestinal system
? Crohn's disease –Phase 2b


Data Management systems experience:

? Oracle Clinical
? Medidata Rave
? DDS
? I- Review
? SAS dataset validation
? MS excels

Trainings Undergone:

? Overview of Clinical Data Management
? Indexing and Discrepancy management
? Medidata Rave
? Inform reporting, Inform for data management
? Medical Terminology
? Good Clinical Practices (GCP)
? Clinical Trials Regulatory Requirements – India
? DM: Quality Assurance and Data Integrity
? SAE Recon Process (includes J&J's Procedural Doc

Work Terms

Hours of Operations : 30 hrs/week
Payment = $15/hr
Mode of Communication : Email and Phone