Job Description Summary
Using advanced data management tools and techniques, provide skilled and lean execution of Data Management products and milestones with respect to cost, quality and timelines for all assigned trials within Clinical Data Acquisition and Management. Ensure consistently high-quality data delivery (in alignment with the Novartis Clinical Data Quality Statement) to analysis and reporting.

Job Description
Major accountabilities:
• Provides DM leadership across assigned trial (s) and Acts as the Trial Data Manager where needed -Demonstrates a business understanding of the compound (s) profile to identify and assist in successful application of data Mgmt processes.
• Provides feedback to assure well written protocols and amendments.
• Recognize and resolve protocol issues that may impact database design, data validation and /or analysis/reporting and that do not make the best use of available standards -Performs DM activities for start up of a study, Data Handling plan , Data Review Plan and performing user acceptance testing (UAT)



-Manage local lab set up for the Clinical Database as applicable -Leads process and training deliverables within platform or processes.
• Accountable for all aspects of the Process and Training within remit to ensure full compliance to all applicable global regulatory requirements is maintained and business objectives are achieved.
• Accountable for all quality related aspects -Centralizes and aligns DO for audits and inspections.
• Manages and measures Quality -Coordinates exception requests, deviations and corrective /preventative action plans -Performs DM hands on activities during the course of the study Performs ongoing review of all data generated from the clinical study including Third party and local lab data as well as SAE reconciliation where applicable -Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation -Has proven abiity to use the too

📌 Senior Clinical Data Scientist (Hyderabad)
🏢 Novartis
📍 Hyderabad