Clinical Scientific Expert I

Role Overview

Major Accountabilities

• Perform clinical data review and trend analysis, supporting interim analysis, database lock, post-lock activities, and resolution of clinical data issues.
• Contribute to Data Review or Quality Plans and ensure protocol requirements, eligibility criteria, and study assessments are implemented consistently.
• Contribute to Case Report Form development and implementation of data capture tools.
• Improve data review processes by identifying delinquent or redundant reports and implementing innovative analysis processes and tools.
• Contribute to regulatory documents, clinical study reports, publications, and pharmacovigilance activities when required.
• Produce training materials, provide team training, and support study-level meetings.
• Develop subject matter expertise and contribute to local or global education and process development initiatives.

Essential Requirements

• An advanced degree in life sciences, healthcare, or a clinically relevant field is required.
• One to two years of relevant clinical study experience, or three to four years in clinical operations or a clinical scientific role, is required.
• Intermediate knowledge of planning, executing, reporting, and publishing global clinical studies is required.
• Good Clinical Practice, drug development, clinical data collection, and reporting knowledge are required.
• Strong scientific knowledge in at least one therapeutic area is required.
• Analytical or computational ability, statistical analysis knowledge, scientific writing skills, and cross-functional collaboration ability are required.
• Experience with Rave or OC-RDC is advantageous.

Workplace and Employment

• The position is listed at the Hyderabad office in India.
• The job type is full time and the employment type is regular.

About Novartis