Shanmukha Sai Twarakavi

Clinical Scientific Manager- i (Clinical Scientific Expert - i) @Novartis India

Hyderabad, IN

Responsibility for ensuring high quality clinical trial data review/insights and analysis as advised by the Integrated Clinical Trial Team (iCTT)• Perform high quality clinical data review and identify clinical data insights through patient level review and trends analysis, supporting Interim Analysis, Database and Post Lock activities and facilitate resolution of clinical data issues.• Collaborate with relevant line functions to improve the quality of clinical data review/insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.• Chips into the development the Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study.• In conjunction with the relevant line functions, may supply to Case Report Form (CRF) development, and support the implementation of data capture tools.• Chip in to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools.• May supply (in collaboration with relevant line functions) to the development of study-level documents, including clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. In collaboration with relevant line functions, review/ write clinical trial documents for study CSR activities, and publications.• May support pharmacovigilance activities (e.g, reviewing/chipping in to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required. Produce training materials and provide training to iCTT.• Led cross-functional collaboration and supported clinical study leadership by ensuring timly delivery of studymilestones

CLINIMINDS, NEW DELHI

Advance post graduate diploma in Pharmacovigilance and clinical research, Health Care and Information Technology

Adikavi Nannaya University, Rajahmundry, East Godawari

Master of Business Administration - MBA, Business Administration and Management, General

NTR University of Health Sciences

house surgeon , Dentistry

NTR University of Health Sciences

Bachelor of Dental Surgery., HEALTH CARE