Mahesh Basavaraj
Principal Clinical Data Manager Novotech
- Role
- Principal Clinical Data Manager at Novotech
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Mahesh Basavaraj
Handling a team of Database Designers, designing complex databases to meet the requirements of adaptive clinical trials. Certified Zelta (formerly IBM Clinical Development) study designer with over 12 years of experience Proficient in setting up RTSM module. Planning inventory requirements for the study. Certified in Data Migrator Module (Zelta). Proficient in setting up Data Migrator Module in Zelta and integrating IWRS with Clinical Database (Zelta). Draft changes to SOPs and create checklist for database development Ability to provide complete end-to-end data management solutions and perform all activities from CRF designing to Database lock. CRF designing, annotation of CRFs as per CDISC specifications, database design testing, writing complete edit check specifications and programming for a study, UAT of edit checks, Implementing change requests to the design setup of the study and handle all the related documents. Lock and closure of projects and archiving activities of the projects. Complete setup of randomisation module with setup of stratification factors as per requirement of the protocol. Complete setup of inventory module and programming of Dispensing module with it being linked to randomisation module and manage drug dispensation through IWRS. Database support for inventory supply management for multiple studies. Leverage information technology in clinical trials to speed up the process so as to squeeze the time for data submission to regulatory agencies. Apply medical judgment gained by the experience of 4 years in medical transcription, 8 years in CDM, and use technology & tools in the field of clinical trials for the key deliverables of CDM. Specialties: B.Sc, Diploma in Computer Applications, Medical Language Specialist, CDM specialist.
Experience
Principal Clinical Data Manager
Jan 2025 — Present
Education
Bangalore University
B.Sc, Physics, Mathematics, Electronics,
1995 — 1998
Indira Gandhi National Open University
CIC, Computers
1998 — 1998
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