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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Director, Clinical Data Management & Systems - **Company:** Ryvu Therapeutics - **Location:** Netherlands (Remote available) - **Experience:** Experienced - **Contract:** Contract - **Skills:** Artificial Intelligence, Clinical Data Management, Clinical Trial Management Systems, Databases, Data Validation, Data Cleansing, Data Visualization, Database Design, Enterprise Document Management System, R (Programming Language), Machine Learning, Oracle (Applications), Power BI, Standard Sql, SAS (Software), Information Technology, Data Management, Spotfire, VeevaVault - **Published:** October 24, 2026 - **Apply:** https://www.vacaturesinfarma.nl/job/ryvu-therapeutics/director-clinical-data-management---systems-02a0ec8fff53f ## About the Role * A university degree in Life Sciences, Biostatistics, Computer Science or a related field. * At least 10 years of experience in clinical data management and/or clinical operations, including 3-5 years in a leadership role. * Proven sponsor-side experience selecting and overseeing CROs or vendors delivering data management services. * Recent hands-on experience in database build, data cleaning, query management and database lock, with a willingness to perform operational work within a small team. * Experience in early-phase oncology or hematology clinical trials. * Practical experience with EDC platforms such as Medidata Rave, Veeva Vault or Oracle InForm. * Knowledge of CDISC standards, including CDASH, SDTM and ADaM, as well as EU CTR/CTIS and FDA data requirements. * Experience with client audits and regulatory inspections, and current GCP training. * Working knowledge of SQL, SAS, R or Python for data review and metrics. * Understanding of outsourcing models, work orders and budget tracking, together with familiarity with risk-based quality management and centralized monitoring. * Strong leadership, problem-solving and stakeholder management skills, including the ability to hold vendors accountable while maintaining constructive working relationships. * The ability to work independently in a lean, fast-paced environment and manage multiple client studies in parallel. * Proficiency in spoken and written English. Nice to have: * Experience building or scaling a data management team. * Clinical trial experience in Europe, particularly Central and Eastern Europe. * Interest in or experience with AI/ML applications in clinical data management. * Familiarity with data visualization tools such as Spotfire or Power BI. * Polish language skills. ## Description * Lead clinical data management, ensuring quality, timely delivery, budget control and compliance with GCP, ICH E6(R3), EU CTR, GDPR and applicable FDA requirements. * Perform and oversee database design, eCRF review, data validation and cleaning, query management, SAE and external data reconciliation, and database lock. * Deliver clean, timely data to support dose-escalation decisions, safety review committees and interim analyses. * Select, qualify and oversee data management CROs and vendors, defining quality metrics, monitoring contractual commitments and managing issues, escalations and corrective actions. * Monitor service scope, timelines and costs in collaboration with Clinical Operations and Finance, and maintain inspection-ready oversight documentation in the TMF. * Select, implement and maintain clinical systems, including EDC, IRT/RTSM, ePRO, eTMF and CTMS, ensuring appropriate validation, access controls and data protection. * Set up and oversee external data transfers and reconciliation for central laboratory, PK, biomarker and imaging data. * Develop and maintain SOPs, Data Management Plans, Data Validation Plans and templates that can be used across multiple client studies. * Provide clients with clear reporting on data status, quality and vendor performance, and collaborate with Biostatistics, Medical Monitoring and Translational Sciences on CDISC-compliant deliverables and clinical study reports. * Contribute to proposals, budgets and client meetings, and represent data management during client audits, regulatory inspections and due diligence activities. * Define the model for an in-house data management team, recruit and develop team members, and gradually transition selected activities from CROs. * Participate in Keelira and Ryvu data and AI initiatives, including evaluating and piloting validated, documented and GDPR-compliant tools for data review, query management, medical coding and reporting., * The opportunity to shape Clinical Data Management & Systems, from processes and technology selection to building an in-house team. * Responsibility for data that supports key decisions in early-phase oncology and hematology studies. * A role combining hands-on delivery, vendor oversight and strategic development. * Close collaboration with multidisciplinary teams and external clients. * Package of benefits: Luxmed, Multisport, PZU * A remote role. We are looking for a Director, Clinical Data Management & Systems to lead clinical data management supporting Phase I/II oncology and hematology studies. In this role, you will combine hands-on data management with oversight of CROs and technology vendors. As our study portfolio grows, you will build and lead an in-house Clinical Data Management team.