Director Clinical Data Standards

Manage a global team(s) of Clinical Data Standards Specialists providing

operational, 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 more

disciplines of data acquisition and tabulation, analysis and reporting and/or

regulatory data submission across multiple disease/therapeutic areas and drug

development 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, business

rules and processes for development, maintenance, deployment and adoption with

a 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 clinical

data 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: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards