Clinical Data Specialist
Location: Hyderabad, AP, India
Division: Biomedical Research
Business Unit: Translational Medicine
Work Location: Hyderabad, AP
Company/Legal Entity: Nov Hltcr Shared Services Ind
Functional Area: Research & Development
Job Type: Full Time
Employment Type: Regular
Shift Work: No
Early Talent: No
About the Role
Join Novartis as a Clinical Data Specialist and contribute to shaping the future of medicine. Your responsibilities will include, but are not limited to:
- eCRF Development: Collaborate on electronic Case Report Form (eCRF) development ensuring data alignment with the protocol.
- Data Collection Requirements: Assess new data collection needs and provide clinical input for the development of clinical Data Standards for CRFs and third-party data collection methodologies.
- Data Transfer Specifications (DTS): Ensure timely setup and finalization of accurate DTS documents and facilitate schedules for rapid data availability and review.
- Data Quality Plan (DQP): Offer expert input focusing on clinical checks and data risks. Conduct regular Clinical Data Reviews (CDR) in consultation with clinical teams, utilizing visual outputs and other tools.
- CDR Meetings: Lead meetings, manage outcomes and actions, and resolve queries related to CDR. Highlight significant risks, trends, data discrepancies, and process deviations at Data Quality Team (DQT) meetings.
- Protocol Deviations (PDs): Identify, track, and resolve PDs as per Novartis processes. Detect potential PDs through regular data reviews, ensure medical review, file monthly PD listings, and detect trends for action.
Commitment to Diversity & Inclusion
We are dedicated to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
- Experience: 3-4 years in Clinical Trial Design, Data Review & Reporting, Clinical Data Management, Pharmacovigilance, or Clinical Project Management.
- Education: Diverse educational backgrounds, including Life Sciences, Healthcare Professionals (Pharmacists, Nurses, Medical doctors, Dentists).
- Skills: Relevant experience in Clinical Data Review and Data Management.