Job Description Summary
Provide timely & skilled ongoing Mgmt of Data Mgmt/Coding/CDDRA-Database Development/DAP deliverables and of clinical trial data with respect to cost, quality and timelines for all assigned trials within Clinical Data Mgmt. Ensure consistently high quality data available for analysis and reporting. Develop content and redefine training modules into engaging & interactive applications. Leverage technology to ensure process simplification and training delivery. Follows Good Clinical Practices (GCP), data-handling procedures and guidelines. Participates in the review of clinical research protocols, reports and statistical analysis plans. Drives participation and input within Data Operations (DO) in the delivery of quality data and programs, processes and documentation -Manage data Load, Transfer and conform of Clinical trial data to NCDS compliant standards.



The position is a key contributor with Data Provisioning team in ensuring that pharmaceutical drug-development plans in Novartis Global Drug Development are executed efficiently with timely and high quality deliverables.

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 startup 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 complia

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