Clinical Data Standards Director

Director Clinical Data Standards

Job Description 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.

Job Description

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.

Skills Desired

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

Experience Level

Executive Level