Director Clinical Data Standards

Summary

Supports Head CDS in setting the standards and automation strategy across Novartis. Manage a global team(s) responsible for executing data standards / automation objectives across DO. Responsible for ensuring quality, scalable, reusable, (CDISC and regulatory) compliant data standards and technologies are transparently deployed across GDO in close collaboration with external industry peers and internal stakeholders delivering stellar customer focus. Responsible for planning and overseeing KPIs/metrics, frameworks,policies, business rules and processes for development, maintenance, deployment. Responsible to ensure Novartis fulfills a ROI across the standards and automation landscape.

About The Role

Manage a global team(s) of Clinical Data Standards Specialists providingoperational, technical and strategic management and development of teams .

• Accountable for all aspects of Clinical Data Standards delivery within assigned
  

discipline including the strategy and planning to ensure the sucessful development
and maintenance of end-to-end s data and reporting standards in one or moredisciplines of data acquisition and tabulation, analysis and reporting and/orregulatory data submission across multiple disease/therapeutic areas and drugdevelopment phases .

• In collaboration with stakeholder and partner functions across and outside of GDO,
  

accountable for driving standards implementation across the organization and
defines and monitors KPIs/metrics, strategies, frameworks, policies, businessrules and processes for development, maintenance, deployment and adoption witha strong focus on scientific and regulatory needs.

• Lead the technical review and assessment of industry and regulatory standards
  

and technologies supporting regular gap/impact analysis and implementation of
action plans where needed.

• Act as an expert consultant /SME providing Clinical Data Standards input to all
  

relevant areas including; electronic data capture/database programming, edit
check programming, report programming, electronic data loads, IVR technology,electronic patient reported outcomes, metadata management and/or other clinicaldata management or analysis data and TFL-related systems.

• Support the development and maintenance of a high performing, industry
  

Recognized Data Operations Organization

• May also represent at internal and external decision boards and deputise for Head
  

CDS as required.

Minimum Requirements

Work Experience:

• People Challenges.
• Functional Breadth.
• Geographic Scope.
• People Leadership.
• Project Management.
• Collaborating across boundaries.
• Representing the organization.
  

Skills

• Automation.
• Biostatistics.
• Clinical Trials.
• Computer Programming.
• Cross-Functional Teams.
• Data Analytics.
• Data Strategy.
• Decision Making Skills.
• Global Project Management.
• Metadata Management.
• Statistical Analysis.
  

Languages :

English.

Why Novartis:

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