Senior Manager / Associate Director, Clinical Data Transparency, EHDS Data Cataloguing

Leiden Bio Science Park; Netherlands; Hybrid; EUR 120,000 - 150,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking a Senior Manager / Associate Director for EHDS Data Cataloguing, reporting to the Director of Clinical Data Transparency. The role leads the EHDS Data Inventory and ensures catalogue information is complete, consistent, and discoverable across geographies.

The position requires advanced data governance expertise, collaboration with Legal, Global Privacy, and Technology, and the ability to embed sustainable cataloging processes for legacy and

Qualifications

• Advanced degree and 8+ years in pharma, healthcare, data.
• Experience with data cataloging, metadata, governance.
• Knowledge of CDISC SDTM/ADaM, HL7 FHIR, HealthDCAT-AP, or DCAT-AP is a plus.

Responsibilities

• Leads EHDS Data Inventory and Cataloging workstream with data owners.
• Maintains complete inventory of in-scope data including ownership and status.
• Applies EHDS data categories and metadata standards.
• Develops minimum metadata requirements, decision framework, and guidance.
• Coordinates with Legal, Privacy, Regulatory teams on ownership and obligations.
• Plans pilot cataloging activities and drives process improvements.

Skills

Clinical Data Standards

Cross-Functional Project Management

International Collaborations

Metadata Management

Education

Advanced degree in scientific/technology/healthcare

Job description

We are searching for the best talent for a Senior Manager / Associate Director, European Health Data Space (EHDS) Data Cataloguing within our Clinical Data Transparency business. The position may be located Beerse, Belgium; Leiden, the Netherlands; High Wycombe/Maidenhead, UK; Allschwil, Switzerland; or Spring House / Titusville / Raritan, United States. The position is Hybrid (3 days onsite weekly). Remote work options may be considered on a case‑by‑case basis and if approved by the company.

Position Summary:

The Senior Manager / Associate Director, EHDS Data Cataloguing is the operational and technical lead for identifying, classifying, describing, registering, and maintaining J&J Innovative Medicine’s in-scope health data under the European Health Data Space. Reporting to the Director, Clinical Data Transparency, Data Sharing, the position leads the EHDS Data Inventory and Cataloguing workstream and is accountable for the completeness, consistency, and ongoing maintenance of catalogue information. The position applies comprehensive knowledge of data cataloging, metadata, classification, data governance, and clinical data to establish a standardized and discoverable view of in-scope J&J Innovative Medicine data. The role coordinates data owners across functions, applies the required EHDS data categories and metadata standards, and works with Data Sharing, Legal, Global Privacy, Regulatory Affairs, and Technology to embed sustainable processes for legacy, in-flight, and future data holdings. The position is dedicated to EHDS and may support closely related Clinical Data Transparency priorities where required to deliver EHDS outcomes or maintain the resulting data cataloging capabilities.

You will be responsible for:

• Leads the EHDS Data Inventory and Cataloging workstream and coordinates data owners and functional representatives to identify the universe of in-scope datasets, data sources, and holdings requiring assessment.
• Establishes and maintains a complete inventory of in-scope data, including ownership, applicable EHDS data category, key asset characteristics, source, status, and relevant dependencies.
• Applies and maintains the classification approach for in-scope holdings against the applicable EHDS secondary-use data categories and implementation requirements.
• Applies the target metadata standard, including HealthDCAT-AP where required, so that catalogue entries are complete, consistent, interoperable, and discoverable by Health Data Access Bodies and prospective data users.
• Develops and maintains the minimum metadata requirements, decision framework, classification guidance, data-owner instructions, and controls required for consistent cataloging across functions and geographies.
• Coordinates with data owners to obtain, validate, and maintain required dataset information; identifies gaps or delays and drives resolution through the appropriate governance channels.
• Supports functions in determining the data holder position for datasets and coordinates with Legal and other subject matter experts where ownership, control, or EHDS responsibility requires assessment.
• Drives completeness and quality reviews of the inventory, identifies gaps in functional or geographic coverage, and coordinates remediation with accountable data owners.
• Registers and maintains dataset descriptions in the required catalogues or submission environments, coordinates corrections when information changes, and leads periodic verification to keep metadata accurate and current.
• Defines and operationalizes the approach to applicable data quality and utility labeling requirements in partnership with relevant subject matter experts and data owners.
• Partners with Data Sharing to ensure catalogue descriptions remain aligned with downstream data preparation, minimization, anonymization or pseudonymization, and intellectual property or trade secret review processes.
• Works with Technology and relevant data architecture teams to define and implement fit-for-purpose solutions for creating, maintaining, controlling, and publishing catalogue information. Business and data owners remain accountable for the accuracy of the information they provide.
• Embeds EHDS data identification and cataloging requirements into processes for new and future data holdings so that the inventory remains current as the data landscape evolves.
• Plans and leads pilot cataloging activities, evaluates findings, and refines processes, controls, guidance, and training before broader implementation.
• Establishes standard operating procedures, work instructions, training, quality controls, and performance measures for data inventory, cataloging, classification, and metadata management.
• Monitors evolving EHDS implementing acts, technical specifications, and catalogue requirements and incorporates confirmed changes into the operating process, metadata approach, and guidance.
• Identifies needs for external services or technology and supports vendor evaluation, onboarding, and oversight, including services for legacy data cataloging or catalogue solution support.
• Provides subject matter expertise, coaching, and practical support to data owners and functional teams; may provide matrix leadership or manage others based on business need.
• Integrates Johnson & Johnson's Credo and Leadership Imperatives into team goals, decisions, and ways of working.

Education and Experience Requirements:

• Advanced degree in a scientific, technology, data, or healthcare discipline, or equivalent experience.
• At least 8 years of relevant pharmaceutical, healthcare, scientific, or data experience in a related discipline, such as data management, data standards, data governance, biostatistics, clinical programming, or clinical data transparency!
• Expertise in data cataloging, metadata management, data classification, data governance, or a closely related discipline.
• Knowledge of clinical and health data standards, such as CDISC SDTM or ADaM and controlled terminology; familiarity with OMOP, HL7 FHIR, HealthDCAT-AP, or DCAT-AP is an advantage.
• Understanding of EHDS data holder obligations, or demonstrated ability to rapidly interpret and operationalize new regulatory and technical requirements.
• Proven experience leading cross-functional projects and coordinating distributed data owners in a matrix environment.
• Experience developing and implementing sustainable data/metadata processes, governance, controls, training, and quality standards.
• Strong communication, interpersonal, and stakeholder management skills, with the ability to build effective partnerships across internal and external networks.
• Demonstrated leadership in problem-solving and decision-making, with the ability to thrive in a fast-paced global matrix environment, manage competing priorities, and support international collaboration and travel as required.
• Some domestic or international travel may be required.

Required Skills:

Clinical Data Standards, Cross-Functional Project Management, International Collaborations, Metadata Management

Preferred Skills:

Advanced Analytics, Analytics Dashboards, Business Behavior, Database Management, Data Governance, Data Management, Data Privacy Standards, Data Savvy, Data Security, Data Stewardship, Emerging Technologies, Information Security Risk Management, Organizing, Performance Measurement, Standard Operating Procedure (SOP), Strategic Thinking, Technical Credibility