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:
Skills:
Languages :English.
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