Clinical Scientific Expert

Role Overview

Major Accountabilities

• Perform clinical data review and identify patient-level insights, trends, signals, risks, and issues affecting data quality, safety, eligibility, and integrity.
• Support interim analysis, database lock, post-lock activities, and resolution of clinical data issues with relevant line functions.
• Contribute to data review and quality plans and ensure protocol requirements and study assessments are implemented consistently.
• Contribute to case report form development, data capture tools, and improvements to data review processes.
• Contribute to regulatory documents, clinical study reports, publications, pharmacovigilance activities, and safety monitoring meetings when required.
• Produce training materials, provide training to the Clinical Trial Team, and support study-level meetings.
• Develop therapeutic-area and clinical data review expertise and contribute to education and process development initiatives.

Essential Requirements

• An advanced degree in life sciences, healthcare, or a clinically relevant discipline is required.
• Master’s, PharmD, MPharm, PhD, MBBS, BDS, or MD is strongly preferred.
• One to two years of scientific, strategic, and operational clinical study experience, or three to four years in clinical operations or a clinical scientific role.
• Intermediate knowledge of planning, executing, reporting, and publishing global clinical studies.
• Good knowledge of Good Clinical Practice and drug development processes.
• Strong scientific knowledge in at least one therapeutic area.
• Knowledge of clinical data collection and reporting using systems and tools such as EDC systems and Excel.
• Analytical or computational background, trend detection ability, escalation judgment, and strong medical or scientific writing skills.
• Ability to collaborate across boundaries, resolve issues, and recognize when escalation is needed.
• Experience with Rave or OC-RDC is advantageous.

Workplace

• The role is based at the Hyderabad office in India.