Head of Data Standards & CRF Design

About the role

This is a global leadership position for the Director of Clinical Data Standards and CRF Design, reporting to a company active in healthcare, life science and electronics. The role leads a team accountable for clinical data standards, CRF design, metadata governance and submission-ready data deliverables. It is based in the Maroussi office in Greece, with 3 days per week on site.

Key responsibilities

• Lead a global team responsible for clinical data standards, CRF design, metadata governance and submission-ready data deliverables.
• Own the operational implementation of standards across CRF, SDTM and non-CRF domains.
• Drive governance and version control in the metadata repository.
• Ensure high-quality study design, eDC CRF design and regulatory submission readiness for SDTM packages in outsourced studies.
• Partner with Clinical Development, Data Management, Biostatistics, Safety, Regulatory, IT, CROs and technology vendors, and with industry forums, to advance standards, inspection readiness and digital innovation.

Required profile

• Advanced degree in Life Sciences, Data Science, Information Systems, Computer Science or an equivalent scientific or technical discipline.
• 10+ years of progressive experience in clinical data standards within a pharmaceutical, biotech or CRO environment, including senior leadership progression.
• At least 5 years leading and developing global, multidisciplinary teams on data standards definition, implementation and cross-functional integration.
• Proven experience in CRF design, eDC study build standards, metadata repository lifecycle management, external data standards and regulatory submission readiness.
• Strong track record in governance, quality oversight, risk management, vendor and CRO partnership and cross-functional decision-making in a regulated clinical development environment.

Required skills

• Deep expertise in CDISC standards and submission deliverables: CDASH, SDTM, Define.xml, annotated CRF (aCRF), SDRG and inspection-ready metadata governance.
• Plus: emerging standards such as Dataset-JSON, SDTM v3.0, CDISC Open Rules, ICH M11, HL7 FHIR-to-CDISC interoperability, and AI-enabled metadata and protocol-to-CRF automation.
• Executive communication, stakeholder influence, change leadership and representation in external standards or industry forums are advantageous.