Ready to shape the future of clinical data standards and influence the success of global oncology studies?
An established global clinical research organisation is seeking a Principal Clinical Data Standards Specialist to join its expanding team. This senior position provides the opportunity to influence data standards strategy, promote consistency across clinical development programmes, and support the adoption of industry best practices within a collaborative and innovative environment.
In this role, you will provide leadership in the development and application of clinical data standards, support regulatory compliance activities, and act as a trusted advisor to cross-functional stakeholders. You will also contribute to strategic initiatives, standards governance activities, and capability development across the organisation.
Responsibilities:
- Serve as a recognised subject matter expert in clinical data standards and associated processes.
- Design, develop, and maintain standards libraries and supporting documentation for clinical data collection.
- Ensure alignment with industry standards, organisational requirements, and applicable regulatory expectations.
- Provide strategic guidance regarding standards implementation across studies and programmes.
- Partner with stakeholders to establish data collection approaches and standards frameworks for clinical research activities.
- Evaluate operational challenges and recommend practical, standards-based solutions.
- Contribute to the enhancement of tools, methodologies, and working practices.
- Support governance activities and provide expert recommendations on complex standards-related topics.
- Lead and participate in cross-functional projects and business improvement initiatives.
- Coordinate contributors and stakeholders when managing standards-focused activities.
- Produce and maintain training resources, guidance documents, and reference materials relating to data standards and terminology.
- Monitor emerging regulations, industry developments, and evolving standards to ensure continued compliance and best practice adoption.
- Provide mentoring, coaching, and technical support to colleagues across the function.
- Communicate recommendations effectively and build consensus among diverse stakeholder groups.
Key Skills and Requirements:
- Bachelor's degree in Life Sciences, Computer Science, Information Management, or a related discipline.
- Significant experience working within clinical data standards, clinical data management, or related functions in the pharmaceutical, biotechnology, or clinical research sectors.
- Strong knowledge of industry standards, including CDASH, SDTM, controlled terminology, and associated submission requirements.
- Understanding of global regulatory expectations and data standards frameworks.
- Experience using electronic data capture (EDC) systems and other clinical technology platforms.
- Demonstrated ability to investigate and resolve complex data standards challenges.
- Experience leading projects, workstreams, or process improvement initiatives.
- Strong communication, presentation, and stakeholder engagement skills.
- Ability to influence decision-making through data-driven recommendations and expert insight.
- Proven track record of delivering high-quality outputs within a regulated environment.
Desirable:
- Advanced degree (Master's, PhD) or equivalent qualification.
- Experience developing standards content for internal libraries and sponsor-facing projects.
- Previous involvement in standards governance groups.
- Experience leading cross-functional process improvement initiatives.
If you are having difficulty in applying or if you have any questions, please contact Elis Jones at e.jonesproclinical.com.
Apply Now:
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