Head Of Data Standards CRF Design All Genders

Job description

This role requires to be on-site in our office in Maroussi, Greece for 3 days per week. Your role: In your role as Director, Clinical Data Standards and CRF Design, you will lead a global team accountable for clinical data standards, CRF design, metadata governance, and submission-ready data deliverables. You will own the operational implementation of standards across CRF, SDTM, and non-CRF domains, drive governance and version control in the metadata repository, and ensure high-quality study design, eDC CRF Design, and regulatory submission readiness fpr SDTM packages in outsourced studies. You will partner across Clinical Development, Data Management, Biostatistics, Safety, Regulatory, IT, CROs, technology vendors, and industry forums to advance standards, inspection readiness, and digital innovation.This is a highly collaborative global role where your leadership directly impacts how fast we bring life-changing solutions to patients. You will find excellent opportunities to grow your career as you lead change and champion clinical data innovation across the organization. Who you are: You hold an advanced degree in Life Sciences, Data Science, Information Systems, Computer Science, or an equivalent scientific or technical discipline. You bring 10 or more years of progressive experience in clinical data standards within a pharmaceutical, biotech, or CRO environment, including demonstrated progression into senior leadership roles. You have at least 5 years of experience leading and developing global, multidisciplinary teams responsible for data standards definition, implementation, and cross-functional integration. You possess deep expertise in CDISC standards and submission-related deliverables, including CDASH, SDTM, Define.xml, annotated CRF (aCRF), SDRG, and inspection-ready metadata governance. You have proven experience in CRF design, eDC study build standards, metadata repository lifecycle management, external data standards, and regulatory submission readiness. You demonstrate a strong track record in governance, quality oversight, risk management, vendor and CRO partnership, and cross-functional decision-making in a regulated clinical development environment. Experience with emerging standards and technologies such as Dataset-JSON, SDTM v3.0, CDISC Open Rules, ICH M11, HL7 FHIR-to-CDISC interoperability, or AI-enabled metadata and protocol-to-CRF automation is a plus. Strong executive communication, stakeholder influence, change leadership, and the ability to represent the function in external standards or industry forums are advantageous.