Director, Clinical Operational Data Governance
At GSK, innovation is at the heart of everything we do as we strive to deliver transformative medicines that improve lives around the globe. The Director, Clinical Operational Data Governance role is at the forefront of this mission, driving the governance and management of clinical operational data that fuels groundbreaking research and development. This role is central to ensuring the integrity and accessibility of operational data that powers our clinical studies, enabling us to bring innovative treatments to patients faster and more effectively. If you re passionate about curating our clinical trial operational data to unlock new possibilities in medicine and want to be a key player in shaping the future of healthcare, this is your opportunity to make a meaningful impact.
Job Purpose
The Director, Clinical Operational Data Governance is accountable for availability of high-quality operational data from our clinical studies (i.e. data in our Clinical Trial Management System (CTMS)). This role supports GSKs mission by driving data integrity, governance, and accessibility to enable informed decision-making for our current and in preparation of our future clinical pipeline and successful clinical operations execution .
Process and Technology Development and Maintenance:
- Serve as the Global Process Owner/Lead for all processes around intake (from internal end-users as well as third parties), management and downstream provisioning of clinical operational data.
- Serve as the Clinical Technology Lead to ensure the maintenance of an appropriate technology landscape that optimally supports the execution of business processes aimed at capturing, maintaining, governing and downstream provisioning of clinical operational data.
Data Governance and Quality Assurance:
- Serve as the Domain Owner for the study-level Clinical Operational Data Domain.
- Own and lead data governance activities for clinical operational data and partner closely with relevant sponsors, data stewards, and other stakeholders across GCO and beyond.
- Maintain and refine data governance strategies and their execution to ensure data integrity, reliability and compliance with external regulations and internal standards.
- Monitor the quality of clinical operational data and ensure appropriate mitigations are taken to resolve data quality issues (e.g. validity, completeness, consistency).
- Ensure effective Data Governance practices are defined and embedded across all functions and with upstream and downstream data domain / system owners addressing key risks to availability, quality, ingestion and consumption of clinical operational data.
Data Management and Integration:
- Oversee the collection, storage, and maintenance of clinical operational data, ensuring data is organized and accessible for analysis and reporting.
- Define and enforce Master Data Management policies, standards, and procedures to ensure high-quality master data.
- Own key data artefacts including data dictionaries, metadata repositories, data domain maps, and data lineage documentation to support data traceability and usability.
- Monitor and maintain the quality and consistency of master data through regular reviews and data cleansing activities.
Stakeholder Management and Communication:
- Serve as the primary point of contact for clinical operational data-related inquiries and issues, providing expert guidance and support to stakeholders.
- Collaborate with cross-functional teams to understand their data needs and ensure clinical operational data aligns with business objectives.
- Develop and deliver training programs in relation to clinical operational data and data collection, management and governance processes as needed.
- Manage key stakeholders to promote a culture of data awareness and quality.
Matrix Management and Continuous Improvement:
- Manage relationships with stakeholders and SMEs fostering a culture of accountability, collaboration and continuous improvement while staying current with industry trends, emerging technologies, and best practices in data management and stewardship.
- Identify opportunities to leverage advanced data analytics, machine learning, and automation to enhance CTMS data management processes.
- Lead cross-functional projects, monitoring and remediation programs as required.
Why You?
Basic Qualifications:
- Bachelors Degree or equivalent in information Systems, Life Sciences, Data Science, or a related field.
- 10+ years of experience in the pharmaceutical or life sciences industry within the field of data management and data governance.
- Proven track record in defining and establishing an organization-wide data governance strategy including stakeholder management.
- Experience in translating complex data concepts and data challenges to non-technical stakeholders.
- Proven experience in leading cross-functional teams, managing multiple projects, and driving stakeholder engagement in a data-driven environment.
- Strong industry experience and understanding of clinical trial processes, regulatory requirements (e.g., FDA, EMA), and data governance principles.
Preferred Qualifications:
- Masters or Doctorate.
- Experience working with CTMS (Clinical Trial Management System) platforms and metadata management tools
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Important notice to Employment businesses/ Agencies
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https: / / openpaymentsdata.cms.gov /
