Associate CDM/DBD

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.