Jyoti Ranjan Nayak
Clinical Developement Clinical Scientific Expert @Novartis
Signup · Get unlimited contacts
WORK HISTORY
Clinical Developement Clinical Scientific Expert @Novartis
Hyderabad, IN
Clinical scientific Expert at Novartis Perform high quality clinical data review supporting Interim Analysis and Database Lock activities and facilitate resolution of clinical data issues. • Collaborate with relevant line functions to advance quality data review with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.• Collaborate with relevant line functions on the development of study-level documents, including clinical sections of key regulatory documents. In collaboration with relevant line functions, review/write clinical trial documents for study Clinical Trial Authorization (CTA), CSR activities, and publications.• Conduct study start-up activities such as overseeing protocol development, CRF & relevant document development, Informed Consent Form development, data analysis plan, reports.• Develop materials for trial-related advisory boards, data monitoring committees, investigator meetings, and protocol training meetings. • Supporting IA, DBL, Post database lock activities and facilitate resolution of clinical data issues. • To enhance the quality of clinical data review/insights with an emphasis on subject safety, data integrity, trend identification, analysis and remediation• Contribute to development of 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.• Contribute to the development of study-level documents, clinical sections of key regulatory documents (such as Investigator’s Brochures) and safety updates. • Reviewing safety narratives for CSR.• Responsible for education, implementation and compliance to standards (SOPs) and best practices for clinical operations within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
EDUCATION
UNIVERSITY DEPARTMENT OF PHARMACEUTICAL SCIENCES
M.Pharm, Pharmacology
University Department of Pharmaceutical Sciences, Utkal University
Bachelor, Pharmacy
ABOUT JYOTI RANJAN NAYAK
This is Jyotiranjan Nayak (M. Pharm in Pharmacology, PGDCR) introducing myself as a Clinical scientific expert. My specialization in Clinical pharmacology and work experience in different phases of Clinical Research & Development (including Pharmacovigilance) enriched my knowledge to excel and expertise in this field. Core competency • In scientific and operational aspects of clinical drug development starting from protocol development to clinical study report (CSR) preparation with high focus on data quality and integrity.• Scientific writing skills and hands on experience in planning, executing, reporting and publishing global study documents (Protocol, ICF, IB, DSUR, PSUR etc) and contributes to the development of electronic Case Report Forms (eCRFs) from clinical perspectives.• Support in developing and implementation of Electronic Patient profiles, Patient Reported Outcomes (ePRO), study specific reports, Data base & tools (EDC- iMedidata, RAVE & Oracle Clinical RDC, JReview, SPOTFIRE).• Development of Data Review Plan/ Data Quality Plan Module (DRP/DQPM) to perform end to end clinical review to support critical milestones like, DMC, Interim Database lock (iDBL), Final Database Lock (DBL).• Diligently review and present clinical trends and scientific insights to Clinical Trial Team (CTT) and boards such as GPT, GCT. Also review close-out documents, narratives and outputs. • Subject Matter Expert (SME) for Protocol Deviation and Expert in data visualizations and identifying Trends using tools, Identifying Clinical Insights & Safety Signals, Creating Dashboards, KPI, QTL Metrics and Other operational Reports• Prepare the training materials required and provide trainings to CRAs and rest of the Clinical Team.• Thorough knowledge of ICH-GCP guidelines, Clinical trial design, Statistical analysis, Regulatory and Clinical development process.My exposure to different regulatory inspections & Audits has given me hands on experience to obtain an enhanced level of understanding to meet the requirements to achieve a strong Drug safety system. My exposure to training/SME team improved my organizational and planning skills as well timely completion of required assignment. My role has also allowed me to improve my management skills which I have developed with the responsibilities of both project and people management.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.