Novartis Hiring Clinical Data Specialist

Novartis; Hyderabad; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Novartis in Hyderabad invites applications for the role of Clinical Data Specialist. You will contribute to global clinical trials and work within a cross-functional team to deliver study outcomes on time, within budget and quality standards.

The role focuses on operational excellence, study start-up activities, data review, and ensuring compliance with SOPs across assigned trials. English language proficiency required.

Qualifications

• Experience in clinical operations and trial management.
• Ability to support study start-up activities and protocol development.
• Knowledge of SOPs and regulatory compliance.

Responsibilities

• Contribute to operational/clinical trial deliverables per timelines and budgets.
• Oversee protocol development, CRF development, and ICF development for study start-up.
• Evaluate sites for trial inclusion and provide capability recommendations.
• Ensure study conduct close-out, drug accountability, and audit readiness.
• Promote SOP compliance and best practices for clinical operations and data review.
• Report technical complaints/adverse events within 24 hours of receipt.

Skills

Trial Planning

OTC Product Development

Post Authorization Data Safety

Regulatory Strategy

Clinical Trial Set-up and Conduct

Job description

Novartis invites you to join team and contribute to groundbreaking medical research. Explore the role, responsibilities, and why Novartis is a leading pharmaceutical company.

About Novartis

Novartis is a global pharmaceutical company dedicated to improving patient lives through innovative medical solutions and digital advancements.

Job Vacancy: Clinical Data Specialist

Location: Hyderabad, Andhra Pradesh, India

Summary

Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team, Contributes to operational excellence through process improvement and knowledge sharing

About the Role

Major accountabilities:

• Contributes to all operational/clinical trial deliverables that are in scope of the specific JD, according to timelines, budget, operational procedures, quality /compliance and performance standards.
• Conduct/Contribute to study start-up activities such as overseeing protocol development, CRF development, Informed Consent Form development.
• May/may not be involved in identifying new sites for clinical trials; analyze capability and make recommendation for trial inclusion.
• Ensuring proper handling of all study conduct and close out activities including but not limited to site close out, final drug accountability and audit readiness of Trial Master File documentation (if in scope of the specific JD).
• Responsible for education, implementation and compliance to standards (SOPs) and best practices for clinical operations/clinical data review activities within assigned clinical trial(s) and within clinical program(s), including sharing lessons learned.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Minimum Requirements:
Work Experience:

• Cross Cultural Experience.
• Operations Management and Execution.
• Collaborating across boundaries.
• Project Management.

Skills:

• Trial Planning and Feasibility.
• Over The Counter Product Development.
• Post Authorization Data Safety.
• Regulatory Strategy.
• Clinical Trial Set-up, Management & Conduct.

Languages :

• English.

Why Novartis?

Novartis is committed to improving and extending people’s lives through innovative solutions and a diverse, inclusive work environment. Join us to collaborate courageously and tackle the world’s toughest medical challenges.