Director, Clinical Operational Data Governance

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 GSK's 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.

Key Responsibilities

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

#LI-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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.

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