Novartis is hiring for the Clinical Scientific Expert I (Clinical Development Scientist) position at its Hyderabad office. The role focuses on clinical trial scientific support, clinical data review, patient safety, data integrity, and the identification of trends and risks associated with clinical trial endpoints.

Candidates with an advanced degree in life sciences or healthcare, along with relevant clinical research, clinical operations, or clinical scientific experience, can review the eligibility requirements and apply online.

Job Details

Positions

Clinical Scientific Expert I (CSE I) – Clinical Development Scientist

The selected candidate will provide clinical and scientific support throughout clinical studies under appropriate guidance. The role involves clinical data review, study quality and compliance, patient safety monitoring, and collaboration with cross-functional Clinical Trial Teams.

Key Responsibilities

• Clinical Data Review: Review patient-level clinical data, identify trends and insights, assess scientific plausibility, and facilitate the resolution of clinical data issues.
• Patient Safety and Data Integrity: Identify potential safety concerns, eligibility issues, data-integrity risks, and cases requiring medical review.
• Data Review Planning: Contribute to Data Review Plans (DRP), Data Quality Plans (DQP), and study-level data review strategies.
• Clinical Data Collection: Support Case Report Form (CRF) development and the implementation of clinical data capture tools.
• Clinical Study Documentation: Contribute to clinical trial documents, including Investigator’s Brochures, safety updates, briefing books, submission dossiers, Clinical Study Reports (CSRs), and publications.
• Pharmacovigilance Support: Assist with aggregate safety reports, patient narratives, and Safety Monitoring Meetings when required.
• Clinical Trial Collaboration: Work with relevant functions across the Clinical Trial Team to maintain study quality, compliance, timelines, and performance standards.
• Training and Meetings: Develop training materials and support study-level meetings, including Investigator Meetings and Data Monitoring Committee (DMC) meetings.
• Process Improvement: Identify opportunities to improve clinical data review processes and analytical tools.

Eligibility Criteria and Qualifications

Candidates must meet the following requirements:

• An advanced degree in life sciences, healthcare, or a clinically relevant discipline.
• Master’s, PharmD, MPharm, PhD, MBBS, BDS, or MD qualifications are strongly preferred.
• 1–2 years of scientific, strategic, and operational experience in planning, executing, reporting, and publishing clinical studies in industry or academia; alternatively, 3–4 years of experience in Clinical Operations or a Clinical Scientific role.
• Intermediate knowledge of global clinical study planning, execution, reporting, and publication.
• Good understanding of Good Clinical Practice (GCP) and drug development processes.
• Strong scientific knowledge in at least one therapeutic area, including disease mechanisms, symptoms, standard treatments, scientific endpoints, and clinical outcomes.

Required Skills

Applicants should have knowledge or experience in the following areas:

• Clinical research and clinical trials
• Clinical data review and data integrity
• Good Clinical Practice (GCP)
• Clinical data collection and reporting
• Electronic Data Capture (EDC) systems
• Microsoft Excel and data analysis
• Statistical analysis methodologies
• Analytical and computational skills
• Medical and scientific writing
• Risk monitoring and trend identification
• Cross-functional collaboration and issue escalation
• Learning design and training development

Additional advantage: Experience with Medidata Rave and/or OC-RDC is an advantage.

Application Link