Clinical Data Specialist

1 week ago

Hyderabad, India Novartis Full time
Your responsibilities include, but are not limited to:

•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.

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