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Precision Medicine Group is expanding its data management capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru. This role is a senior individual-contributor authority for Technical Data Management, responsible for shaping functional strategy and technical governance across strategic programs.
Key Responsibilities:
• Protocol & Requirements Translation: Define enterprise expectations for requirements quality and traceability, advise on novel study designs, and resolve critical requirements issues across strategic programs.
• CRF, Edit Check & Technical Specifications: Provide governance for the full suite of technical specifications, shape and harmonize CRF-aligned templates and design principles across platforms, portfolios, and therapeutic areas, create data transfer agreements, and arbitrate high-impact technical design decisions.
• Database Design & Build Oversight: Establish technical architecture and governance expectations for database delivery, advising leadership on strategic design trade-offs, platform capabilities, interoperability, AI enablement, and systemic technical risk.
• Testing, Defect Management & Validation: Define technical testing standards and quality thresholds, provide assurance for critical validation issues, sponsor advanced automation, and establish expectations for technical execution and evidence.
• Production Readiness, Migration, Change Control & Archival: Provide governance for major migrations, platform transitions, post-production change, and technical database archival within selected EDC systems; direct response to critical deployment or archival risk.
• Data Integration & Workbench Enablement: Shape integration and data-cleaning workbench strategy, long-term technical architecture, operating models, data lineage, control points, and interoperability across clinical data platforms.
• Quality, Compliance & Documentation: Represent Technical Data Management in strategic governance and sponsor forums; define technical quality and inspection-readiness expectations; lead strategy for business-critical programs; build organizational capability; sponsor innovation and transformation.
The role directs resolution of the most complex or high-risk challenges, influences sponsor and internal technology decisions, develops technical capability across the function, and sponsors innovation and process transformation.
REQUIREMENTS:
Minimum:
• Bachelor's degree in a relevant discipline or equivalent training and experience
• Typically 12+ years of relevant experience, including enterprise- or portfolio-level technical leadership and delivery of major improvements or transformations
Preferred:
• Advanced degree or recognized technical leadership credentials, together with demonstrated competencies in enterprise strategy, governance, architecture, compliance, and transformation
• Equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job
Required Knowledge, Skills, and Competencies:
• Recognized expert knowledge of technical clinical data strategy, governance, compliance, inspection readiness, and evolving industry practices
• Broad and deep expertise across clinical data platforms, architecture, EDC, integrations, workbenches, data flows, standards, testing, migration, and archival
• Ability to define enterprise requirements, specification, testing, quality, traceability, and technical governance expectations
• Ability to shape technology strategy, technical architecture, library development, interoperability, AI enablement, and evaluation of emerging capabilities
• Exceptional judgment and enterprise thinking when directing resolution of unprecedented or business-critical technical challenges
• Ability to lead technical strategy for the most complex programs and inform capacity, capability, resourcing, and investment planning
• Trusted strategic communication and the ability to influence senior stakeholders, sponsors, vendors, and major internal and external governance forums
• Ability to define sustainable change-control, migration, platform-transition, archival, preventive-control, and inspection-readiness practices
• Ability to build organizational technical capability, develop successors and technical leaders, sponsor innovation, and establish adoption measures
• Exemplary technical leadership, ethical judgment, client focus, accountability, inclusive collaboration, professionalism, and sustained organizational impact
