Head of Data Standards & CRF Design (all genders)
Merck Healthcare
Πλήρης απασχόληση Μακρινός
Εργασία εξ αποστάσεως
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
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
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
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
- Must have: Advanced degree in Life Sciences, Data Science, Information Systems, Computer Science, or an equivalent scientific or technical discipline.
- Must have: 10–15+ years of progressive experience in clinical data standards within a pharmaceutical, biotech, or CRO environment, including progression into senior leadership roles.
- Must have: At least 5 years of experience leading and developing global, multidisciplinary teams responsible for data standards definition, implementation, and cross-functional integration.
- Must have: Deep expertise in CDISC standards and submission-related deliverables, including CDASH, SDTM, Define.xml, aCRF, SDRG, and inspection-ready metadata governance
- Must have: Proven experience in CRF design, eDC study build standards, metadata repository lifecycle management, study metadata, external data standards, and regulatory submission readiness.
- Must have: Strong track record in governance, quality oversight, risk management, vendor/CRO partnership, and cross-functional decision-making in a regulated clinical development environment.
- Preferred: Experience with emerging standards and technologies such as Dataset-JSON, SDTM v3.0, CDISC Open Rules, ICH M11, HL7 FHIR-to-CDISC interoperability, and AI-enabled metadata or protocol-to-CRF automation.
- Preferred: Strong executive communication, stakeholder influence, change leadership, and ability to represent the function in external standards or industry forums.
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
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