Director, Head of Clinical Data Standards & CRF Design
Company: Carrot Recruitment Agency
- Location: London, United Kingdom
- Work mode: Hybrid
- Seniority: Director
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Director, Head of Clinical Data Standards & CRF Design
Location: UK or Greece | Hybrid – 3 days onsite
The Company
An exciting opportunity to join a leading global pharmaceutical company driving investment in innovation for continued 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 pharmaceutical company.
