Director, Head of Clinical Data Standards

Job ID: 17548 | Type: Permanent | Expertise: Clinical Research

Recruiter: Debbie Anderson (Founding Director)
Email:
Phone: +44 (0)

The Company

An exciting opportunity to join a leading global biopharmaceutical organisation with a strong commitment to advancing clinical research and delivering innovative treatments to patients worldwide. With an extensive global development portfolio and continued investment in digital innovation, the business is looking for an experienced leader to drive excellence in clinical data standards, CRF design and regulatory submission readiness.

The Role

You will lead a global team responsible for ensuring clinical data standards are consistently implemented across clinical development programmes. This is a highly visible leadership position, combining technical expertise, operational excellence and strategic collaboration to drive quality, efficiency and innovation across clinical data management.

Key responsibilities include:

• Lead and develop a global team of Data Standards Experts and CRF Designers.
• Oversee the implementation of CDISC standards, including CDASH, SDTM and associated regulatory deliverables.
• Drive consistency and quality in CRF/eCRF design, EDC study build standards and clinical data collection.
• Lead metadata governance, standards management and version control across clinical development programmes.
• Ensure SDTM transformation processes and submission-related deliverables meet regulatory requirements.
• Drive continuous improvement, automation and digital innovation across clinical data standards and processes.
• Provide oversight of external CROs and technology partners to ensure quality and compliance.

You

You will be an experienced clinical data standards leader with a strong technical background and proven ability to manage global teams and implement standards across complex clinical development programmes.

You will bring:

• Extensive experience in clinical data standards within the pharmaceutical, biotechnology or CRO industry.
• Strong experience leading and developing global or multidisciplinary teams.
• Extensive knowledge of CDISC standards, particularly CDASH, SDTM, Define.xml, annotated CRFs and regulatory submission requirements.
• Strong experience in CRF/eCRF design, EDC systems and clinical data standards implementation.

This is an excellent opportunity to take ownership of a critical global function and play a key role in shaping how clinical data is collected, standardised and delivered across a leading biopharmaceutical organisation.