Benila Thomas

Bangalore, Karnataka, India

Yearly Stats: $0 Earned |

Clinical Data Manager

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 Documents)
? Trial Specific SAS Datasets review/QC/Validation
? SDTM: Brief overview of SDTM (From CDM perspective)
? Edit check specifications-Entry & validation of Back end check or SAS listing
? EDC Data Cleaning Plan
? CRF/(e)CRF Completion Guidelines
? Freeze and Lock Process Functionality for the EDC System - Medidata Rave
? CAPA
? HPQC training: ONLY for Co-Ordinators
? External Data review Processes and query management
? Unblinded data management Policy
? Protocol interpretation
? ADLS (Advanced Data Loading System)
? Barnet GCP
? IAPP (Information Asset Protection Policy

Achievements
Research paper accepted for publication:
? Bhaskar, N., Benila, T., Radha, C., and Lalitha, R. G. 2006. Optimisation of enzymatic hydrolysis of visceral waste proteins of Catla (Catla catla) for preparing protein hydrolysate using a commercial protease-Journal of Bioresource Technology. Available online at www.sciencedirect .com (DOI: 10.1016/j.biortech.2006.12.015)
Papers presented in seminars / Conference:
? Bhaskar, N., Benila, T., Radha, C., and Lalitha, R. G. 2006. Optimisation of enzymatic hydrolysis of visceral waste proteins of Catla (Catla catla) for preparing protein hydrolysate using a commercial protease. 18th Indian Convention of Food Scientists and Technologists (ICFOST- 2006), Nov 16-17.Hyderabad, India.
? Presented a Paper in National symposium on “Bio-industrial foc

$15 / Hour
$50 minimum budget

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