Novartis Hiring Clinical Data Specialist

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

Role Responsibilities

As a Clinical Data Specialist at Novartis, your responsibilities will include:

•  Contribute to electronic Case Report Form (eCRF) development with a thorough understanding of data to be collected and in alignment with the protocol.
• Support the assessment of new data collection requirements in assigned studies and provide clinical input into the development of new and updated clinical Data Standards (for CRFs as well as 3rd party data collection methodologies) for assigned trials/therapy areas as needed.
• Provide timely information for, and support the setup and finalization of, accurate and high-quality Data Transfer Specification (DTS) documents.
• Help define a timely transfer schedule for rapid data availability and review. Act as facilitator / problem solver between all parties involved (e.g., clinical functions, data operations, vendors) to streamline and accelerate DTS finalization and revision.
• Provide expert input into the Data Quality Plan (DQP) with a focus on clinical checks (e.g., using standard library checks and accounting for study-specific needs) and data risks.
• Conduct regular Clinical Data Reviews (CDR) in consultation with the Clinical Data Analyst and clinical team (e.g. routine review, for DB lock, Interim Analysis, Snapshots etc) and according to the DQP, utilizing visual outputs, listings, and other outputs as appropriate.
• Lead CDR meetings, keep track and file CDR meetings outcomes and actions. Raise and resolve queries related to CDR in the clinical database. Highlight any significant risk, trend, data discrepancies, process deviations at Data Quality Team (DQT) meetings.
• Identify, track and resolve Protocol Deviations (PDs) as per Novartis processes. Detect potential PDs based on regular clinical data review, evaluate non-important PDs, ensure medical review as needed, file monthly PD listing, detect trends and take actions as required.

Role Requirements

• 3-4 years of relevant experience in Clinical Trial Design and Data Review & Reporting.
• Diverse educational backgrounds, including Life Sciences, Pharmacists, Nurses, Medical doctors, or Dentists.
• Experience in Clinical Data Management, Pharmacovigilance, and Clinical Project Management.

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.

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