Associate Director, Individual Human Data Steward

GSKUpper Providence, PA
2dHybrid

About The Position

This role is all about safeguarding the quality, consistency, and reliability of Individual Human Data (IHD). As the IHD Data Steward, you’ll be the operational expert who ensures that critical R&D data is accurate, standardized, traceable, and always audit‑ready. You’ll bring governance to life by embedding established data standards, managing metadata and lineage, and keeping our data processes running smoothly and compliantly. From handling complex query and rule versioning to resolving data quality issues, you’ll be the hands-on custodian who makes sure IHD stays fit for purpose across its entire lifecycle. Working closely with both technical and business teams, you’ll play a key role in enabling high-quality data that supports GSK’s scientific and operational needs. This is an opportunity to influence how data is governed in practice and to continuously improve stewardship processes that directly support R&D excellence. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK

Requirements

  • Bachelor’s or Master’s degree in Computer Science, Data Management, Health Informatics, Biostatistics, or a related scientific/technical field.
  • Proven experience in data stewardship or data management within a complex, highly regulated R&D environment, ideally in pharmaceutical or clinical research, with specific expertise in managing and governing IHD.
  • Hands-on experience with data lifecycle management, including acquisition, curation, metadata documentation, lineage tracking, and secure long-term retention, in daily operations.
  • Strong understanding and practical application of data standards (e.g., CDISC, controlled terminology, master data), metadata management, data lineage, and data quality frameworks.
  • Experience implementing enterprise governance policies, access controls, and risk management at the operational level, ensuring audit readiness and transparent workflows.
  • Excellent communication, influencing, and stakeholder engagement skills, with proven ability to work effectively across scientific, operational, regulatory, and technical teams in a matrix environment to ensure data fitness for purpose.
  • Ability to lead or actively engage communities of practice, share best practices, and drive adoption of governance standards within functions or areas.
  • Demonstrated ability to analyse data challenges, propose solutions, and communicate effectively with both technical and non-technical stakeholders.

Nice To Haves

  • Familiarity with FDA, EMA, ICH, GxP requirements and global data privacy regulations (GDPR, HIPAA).
  • Demonstrated ability to operationalize compliance and ethical guidelines in partnership with technical and scientific teams.
  • Proficiency with data governance platforms, data catalogues, and data quality tools used to manage and ensure the integrity of IHD assets.
  • Proficiency with SQL/R/Python programming/query languages.
  • Knowledge of, and experience with agile workflow.
  • Experience with best practices for the R&D data lifecycle, with strong attention to detail and ability to manage complex datasets in a compliant manner.

Responsibilities

  • Lead efforts to ensure the accuracy, completeness, and integrity of IHD by maintaining high‑quality, audit‑ready data aligned with FDA, EMA, ICH, GxP, and other global requirements.
  • Execute enterprise data governance policies at the operational level including access controls, data privacy (GDPR/HIPAA), and adherence to internal governance frameworks and proactively identify issues or risks.
  • Develop and manage queries and rules to ascertain clinical study data reuse consent status, ensuring comprehensive traceability to datasets, specific data elements (columns/slices), and defined applicability periods.
  • Define and enforce data standards (e.g., CDISC, controlled terminology, master data) to ensure consistency across clinical, safety, manufacturing, and commercial domains.
  • Lead data lifecycle management including acquisition, curation, metadata documentation, lineage tracking, and secure long-term retention.
  • Support audit readiness and compliance by maintaining transparent, standardized, and traceable documentation and data workflows.
  • Lead compliance and risk‑management activities by adhering to relevant policies and regulations within IHD.
  • Proactively identify IHD‑specific risks, escalate issues when necessary, and ensure ethical data use and privacy are embedded across all data handling processes.
  • Champion data stewardship principles by embedding quality and compliance into daily operations, tracking and reporting on stewardship KPIs for IHD.
  • Lead and engage a community of IHD champions to share best practices, support implementation, and drive adoption of governance standards within their functions or areas.
  • Contribute to the enterprise steward community of practice by sharing IHD best practices and lessons learned.
  • Lead the ongoing maintenance, enhancement, and development of IHD guidance, working closely with key stakeholders.
  • Identify operational best practices and process improvements for data stewardship, leading crossfunctional alignment by serving as the bridge between scientific, operational, regulatory, and technical teams to ensure data is fit for purpose.

Benefits

  • competitive salary
  • annual bonus based on company performance
  • healthcare and wellbeing programmes
  • pension plan membership
  • shares and savings programme
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service