Principal RWE Research Analyst

• Drive the implementation of data analytics reports and dashboards for optimal data review by working with the users to establish robust user specifications and with programmers to implement the optimal output -Translate business requirements into logical models and provide direction to the development team to translate business logic.
• Lead authoring of the user requirements document, functional specifications and functional testing scripts -Proactively identify or address needs for optimal data review working with users and programmers as appropriate.
• Implement and execute robust project plans for delivery, ensuring customer needs are addressed in a timely manner.
• Provide coordination between the project resources so that deadlines are met on deliverables.
• Drive development of appropriate user training.
• Drive all necessary change management activities related to implementation of new data review tools / reports as related to data cleaning, review and visualization.
• Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.

CDS Role

• Lead and contribute to Clinical Data Standards definition, development, validation and support within assigned standards discipline (domain) including the development and maintenance of associated metadata, documents, business rules and guidelines where applicable.
• Define and deliver to robust, priority driven standards development plans for assigned area to ensure agreed deliverables are met and assigned resources are fully and effectively utilized.
• Responsible for driving the efficient, high quality and timely implementation of new standards and/or updates to standards for:a.
• Data Acquisition and Tabulation standards Or/and; b.
• Analysis and Reporting Data Standards4.
• In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development, ensure the accurate translation of scientific and analytical requirements into efficient, compliant standards.
• Support and ensure the appropriate and efficient governance and approval of global and project/study specific clinical data standards liaising with governance boards as needed.
• Contribute to the technical review and assessment of industry and regulatory standards and guidelines supporting regular gap/impact analysis & implementation of action plans where needed.
• Communicate an

• Timely execution of of projects and data requests -Feedback from project sponsors and key stakeholders -Adherence to Novartis policy and guidelines -Metrics and Adherence to KPIs

• Operations Management and Execution.
• Cross Cultural Experience.
• Managing Crises.
• Functional Breadth.
• Collaborating across boundaries.

• English.