Major accountabilities:

• 1. Contribute to LSH and Data Loading activities as Clinical Database Programmer for phase I to IV clinical studies in Novartis Global Drug Development.
• 2. Participate in the review of Data Transfer specification documents and provide comments if required. Also perform Data Loading activities so that data flow is available once the third party data is obtained from external vendors. Address QC findings prior to Production Loads.
• 3. Responsible for Data Loading for all models (both inbound/outbound for both Legacy/future models).
• 4. Responsible for Study Conduct activities that includes Conformance of Clinical data to internal Novartis data formats and continuous flow of data to downstream systems. Perform Masking/Blinding activities as per the Data management Plans and perform testing before providing to the stakeholders.
• 5. As part of the Setup activities, responsible for the maintenance and daily operational support that includes Data processing activities during Study conduct like reviewing Job Logs, address Error/Failure notifications, blinding process of Third Party Data.
• 6. Communicate with all affected parties including Quality Manager, Data Manager, Database Programmer, CRO Personnel and Third Party Vendors.
• 7. Need to have good understanding of Metadata management and impact of Data elements within Metadata and potential impact on Study deliverables.
• 8. Participate in all Subject matter expert (SME) activities and help on any functional testing activities.
• 9. Build and maintain effective working relationship with cross-functional team.
• 10. Comply and adhere to Novartis SOPs with standards and processes to support the LSH Setup and Data Loading Activities.
• 11. Ensure timely and quality development and validation of Deliverables for study-documents according to specifications.
• 12. Responsible for quality control and audit readiness of all Setup activities and deliverables as well as accuracy and reliability of setups.
• 13. Under minimal guidance participates in establishing successful working relationship on individual studies with external associates according to agreed contract and internal business guidance.
• 14. Contribute to assigned parts of process improvement, standardization and other non-clinical initiatives.

Key performance indicators:

• Quality and timeliness of statistical programming deliverables and contributions as assessed by the Lead Programmer/Trial Programmer and the functional/operational manager.
• Effectiveness of communication and team behaviors as assessed by the cross-functional team members.

Minimum Requirements:
Work Experience:

• 1. Ideally 2-5 years of work experience in a programming role preferably supporting multiple clinical trials across various therapeutic areas.
• 2. Good understanding of Mapping, ETL or Data Warehousing activities.
• 3. Good understanding of Metadata Standards Management like CDISC SDTM, LSH.
• 4. Good knowledge of Global Clinical Trial Practices, procedures and Data presentation.
• 5. Good understanding of related applications that are Data collection tools (like OC, Rave) and ancillary data.
• 6. Good understanding of Regulatory requirements.
• 7. Good communications and negotiation skills, ability to work well with others globally.