Clinical Data Specialist II

Novartis; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Novartis Hyderabad is seeking a Clinical Data Specialist II to ensure timely, compliant delivery of global clinical trials. You will review data, support start-up, and maintain audit-ready Trial Master Files while driving process improvements and knowledge sharing across the Clinical Trial Team.

You will contribute to operational excellence, adhere to regulatory requirements, and help drive high-quality outcomes in a complex, global development program from start-up to close-out.

Qualifications

• Budget management related to clinical trials and data operations.
• Experience in clinical data review and ensuring data integrity.
• Familiarity with study start-up activities, protocol development, and ICF creation.

Responsibilities

• Oversee operational and clinical trial deliverables, ensuring on-time, on-budget, and compliant execution.
• Lead or support study start-up activities including protocol development, CRF design, and ICF creation.
• Manage study conduct and close-out with audit-ready Trial Master Files.
• Educate and enforce adherence to SOPs, standards, and best practices, sharing lessons learned.

Skills

Budget Management

Clinical Research

Clinical Trial Protocol Development

Clinical Trials Execution

Coaching and Mentoring

Data Analysis and Integrity

Learning Design

Risk Monitoring

Trends Analysis

Job description

Summary As a Clinical Data Specialist II at Novartis, you play a pivotal role in ensuring the successful delivery of global clinical trials by adhering to schedule, budget, and compliance standards. You will be involved in all aspects of clinical trial activities, from study start-up to close-out, and will provide critical support through data review and insights. You contribute to operational excellence by improving processes, sharing knowledge, and supporting the clinical development process. As a core member of the Clinical Trial Team (CTT), you will help drive high-quality outcomes and maintain rigorous adherence to Novartis policies and regulatory requirements.

About the Role Major Accountabilities:

• Oversee and contribute to all operational and clinical trial deliverables, ensuring they are completed on time, within budget, and in compliance with quality and performance standards.
• Lead or support study start-up activities, including protocol development, CRF design, and Informed Consent Form creation.
• Manage study conduct and close-out activities, ensuring proper documentation and audit readiness of Trial Master Files.
• Educate and enforce adherence to clinical operations standards, SOPs, and best practices, and actively share lessons learned.
• Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours.
• Distribute marketing samples where applicable.

Key Performance Indicators:

• Deliver trials and related activities timely, efficiently, and within budget while meeting quality standards.
• Develop proactive operational plans with effective risk mitigation strategies.
• Maintain strict adherence to Novartis policies, guidelines, and external regulations.

For Clinical Scientific Expert II:

• Consistently perform high-quality clinical data reviews, meeting Novartis standards and ensuring inspection readiness.
• Contribute effectively to study/program level documents, including IDPs, protocols, ICFs, and clinical sections of CTAs.
• Demonstrate leadership by supporting team competency building, leading local/global initiatives, and sharing best practices across programs and departments.

Minimum Requirements Work Experience:

• Financial Management
• Collaboration across boundaries
• Operations Management and Execution
• Project Management

Skills:

• Budget Management
• Clinical Research
• Clinical Trial Protocol Development
• Clinical Trials Execution
• Coaching and Mentoring
• Data Analysis and Integrity
• Learning Design
• Risk Monitoring
• Trends Analysis

Languages:

• Proficiency in English

Why Novartis

At Novartis, we believe that transforming healthcare requires more than just cutting-edge science. It demands a community of dedicated, passionate professionals working together to achieve breakthroughs that improve patients' lives. Join us in creating a brighter future through collaboration and innovation. Explore more about our values and culture here and connect with our talent community here.

Division: Biomedical Research

Location: Hyderabad, India

Company / Legal Entity: Novartis Healthcare Private Limited

Functional Area: Research & Development

Job Type: Full-time .