Job Description Summary

-Assist in the timely & professional ongoing Mgmt of data amangement/Coding deliverables and Clinical Database Delivery/DAP data with respect to cost, quality and timelines for assigned trials managed within Clinical Data Mgmt. Ensure high quality data available for analysis and reporting. Support content development and upgarde to training modules into engaging and interactive applications. Follows Good Clinical Practices (GCP), data-handling procedures and guidelines. Supports quality deliverables within Data Operations (DO). Supports the delivery of quality data and programs, processes and documentationcontributor role in ensuring that pharmaceutical druq-development plans in Novartis Global Drug Development are executed efficiently with timely and high quality deliverables.

 

Job Description

Major accountabilities:

• Demonstrates potential for technical proficiency, scientific creativity, collaboration with others and independent thought.
• Under supervision provides input into writing specifications for study specific validation checks and necessary reports to ensure high quality and consistent data -Involved in User acceptance testing (UAT) and managing local lab set up for the Clinical Database as applicable -Under supervision, participates in ongoing review of all data generated from the clinical study including third party and local lab data and SAE reconciliation where applicable -Supports the development of communications for initiatives.
• Creates under supervision and learns new mediums to create graphics for training and operational application -Participates in PSC activities for Quality Compliance, Audit Readiness and drives CAPAs -Ensures any deviation identified is reported to the Group Head -Ensures activities that are performed are done with quality and understanding of the process -Assists in tracking and reporting status of assigned tasks and ensures appropriate tracking systems are up to date and accurate -Performs accurate and consistent coding, managing coding -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across Data Mgmt activities & deliverables.
• No critical audit findings due to Data Mgmt -Adherence to Novartis policy and guidelines -Customer / partner/ project feedback and satisfaction

Minimum Requirements:
Work Experience:

• Collaborating across boundaries.

Skills:

• Clinical Data Management.
• Data Entry.
• Data Management.
• Data Science.
• Databases.
• Detail Oriented.

Languages :

• English.

 

Skills Desired

Clinical Data Management, Databases, Data Entry, Data Management, Data Science, Detail-Oriented