The posting
We’re expanding our data management capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Principal Technical Data Specialist to help build the foundation of this new regional technical data management organization!
The Senior Principal Technical Data Specialist is the senior individual-contributor authority for Technical Data Management. The role shapes functional strategy and technical governance across strategic programs; defines enterprise expectations for requirements, specifications, architecture, testing, integration, migration, archival, and quality; and ensures programmed outputs align with approved requirements before production use.
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.
Main Duties & 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 while supporting overall coordination by the Lead Data Manager.
- 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 and define sustainable practices.
- 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 / Cross-Functional & Sponsor Collaboration / Program Complexity, Planning & Risk Management / Mentoring, Standards & Continuous Improvement: 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; and ensure sustainable value.
Education and Experience:
Minimum Education & Experience:
- Bachelor’s degree in a relevant discipline or equivalent training and experience; and typically 12+ years of relevant experience, including enterprise- or portfolio-level technical leadership and delivery of major improvements or transformations.
Preferred Education & Experience (optional):
- Advanced degree or recognized technical leadership credentials, together with demonstrated competencies in enterprise strategy, governance, architecture, compliance, and transformation. Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.
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.
#LI-AG2 #LI-REMOTE
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