At a Glance
- Tasks: Shape clinical data standards and lead innovative projects in global oncology studies.
- Company: Established global clinical research organisation with a collaborative culture.
- Benefits: Competitive salary, professional development, and opportunities for mentorship.
- Other info: Dynamic role with excellent career growth and the chance to mentor others.
- Why this job: Make a real impact on clinical research and influence industry best practices.
- Qualifications: Experience in clinical data standards and a degree in Life Sciences or related field.
The predicted salary is between 51750 - 63250 £ per year.
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.
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.
Lead and participate in cross-functional projects and business improvement initiatives.
Produce and maintain training resources, guidance documents, and reference materials relating to data standards and terminology.
Provide mentoring, coaching, and technical support to colleagues across the function.
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.
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.
Ability to influence decision-making through data-driven recommendations and expert insight.
Proven track record of delivering high-quality outputs within a regulated environment.
Advanced degree (Master's, Ph D) or equivalent qualification.
Experience developing standards content for internal libraries and sponsor-facing projects.
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Principal Data Specialist in London employer: ProClinical
Join a globally recognised biopharmaceutical organisation that prioritises innovation and collaboration in the field of protein science and biologic drug development. With a strong commitment to employee growth, you will have access to continuous learning opportunities and be part of a supportive team dedicated to delivering life-changing therapies. Located in a vibrant area, this role not only offers meaningful work but also a dynamic work culture that values your contributions and fosters professional development.
