Ravichandra Kotakonda
- Role
- Clinical Scientific Expert ll, Senior Manager-oncology Ta at Novartis
- Location
- Hyderabad, IN
- LinkedIn followers
- 500 followers
About Ravichandra Kotakonda
A medical graduate with 15 years of work experience in KPO, CRO and Core Pharma…
Experience
Clinical Scientific Expert ll, Senior Manager-oncology Ta
May 2021 — Present
Oncology (Solid Tumors) TA • Responsible for ensuring the collection, review/reporting of high quality trial data, and study reporting/publishing in compliance with Novartis processes, GCP/ICH and regulatory requirements. In addition, responsible for ensuring high quality scientific inputs (under supervision) to the clinical development process and support program level activities as assigned. • Provide scientific leadership in the innovative design, execution, and interpretation of clinical trials in one or more development programs. • Provide clinical and scientific input and contribute to clinical sections of trial and program level regulatory documents (e.g, Investigator’s Brochures, DSUR, PSUR and responses to Health Authorities). • Lead development of quality metrics and data review plan for assigned studies • Review EDC and query management for medical monitoring of the trials • Review and help set up eCRF, eCRF instruction, and data checks. • During the course of the clinical trial, author manual patient narratives for SAEs, AESIs, and AEs that lead to Discontinuation of Study Drug (DAEs) when required. After Database Lock, finalize manual patient narratives and ensure they are submission-ready. • Support and contribute to medical monitoring of trials by preparing documents such as medical monitoring plan • Review and contribute to study-related documents such as: protocols, medical monitoring plans, statistical analysis plans, data management plan, eCRFs, eCRF completion guidelines, database edit checks, risk-based monitoring plans, and provide trainings as needed to site personnel • Effectively work together with colleagues from different departments such as Data management, statistician, Clinical operations, Patient safety, and centralized monitoring group • Develop and review the study specific protocols, informed consent, investigator’s brochure, CSR, etc. • Review TFLs, listings and support IDMC meetings by preparing materials and presenting the data
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