Clinical Development Scientist

Overview

Contributes, with appropriate oversight, to relevant aspects of global clinical trial activities and provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D. Serves as a core member of the Clinical Trial Team and applies clinical data review principles to identify insights, trends, signals and risks related to trial endpoints and patient safety.

What you'll do

• Perform high-quality clinical data review and identify clinical data insights through patient-level review and trends analysis.
• Support Interim Analysis, Database and Post Lock activities and facilitate resolution of clinical data issues.
• Collaborate with relevant line functions to enhance clinical data review and insights, emphasizing subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
• Contribute to development of the Data Review/Quality Plan and data review strategy.
• Ensure protocol-level deviations, eligibility criteria, study assessments and other protocol aspects are implemented consistently across the study.
• Contribute to Case Report Form development and support implementation of data capture tools.
• Contribute to and facilitate data review process improvements, including identification of delinquent or redundant reports and implementation of innovative data analysis processes and tools.
• Contribute to development of study-level documents, including clinical sections of Investigator’s Brochures, briefing books, safety updates and submission dossiers.
• Review or write clinical trial documents for study CSR activities and publications.
• Support pharmacovigilance activities, including reviewing or contributing to aggregate reports and patient narratives and attending Safety Monitoring Meetings, if required.
• Produce training materials and provide training to iCTT.
• Support or present at study-level meetings, including Investigator Meetings and Data Monitoring Committee meetings, as required.
• Develop subject matter expertise in disease areas, clinical data review tools or processes.
• Contribute to line function initiatives and local or global education and process development projects, as required.

What you'll need

• Advanced degree in life sciences, healthcare or a clinically relevant degree.
• 1-2 years of scientific, strategic and operational experience in planning, executing, reporting and publishing clinical studies in industry or academia, or 3-4 years in a Clinical Operations or Clinical Scientific role.
• Intermediate knowledge of planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization, or similar experience with an academic research institution.
• Good knowledge of Good Clinical Practice and drug development processes.
• Strong scientific knowledge in at least one therapeutic area, including understanding of basic disease mechanisms and associated symptoms, standard of care or treatment, scientific endpoints and clinical outcomes.
• Knowledge of clinical data collection and reporting principles.
• Ability to use systems and tools such as EDC systems and Excel for data collection, analysis and reporting.
• Analytical or computational background and ability to detect data trends and escalate as appropriate.
• Knowledge and application of statistical analysis methodology.
• Good medical or scientific writing skills.
• Ability to collaborate across boundaries for shared success and resolve issues or understand when to escalate.

Nice to have

• Master’s, PharmD, MPharm, PhD, MBBS, BDS or MD.
• Experience in Rave and/or OC-RDC.
• Clinical Research skills.
• Clinical Trials skills.
• Data Integrity skills.
• Learning Design skills.
• Risk Monitoring skills.

Details

• Location: Hyderabad.
• Office-based role.