Director, Clinical Data Management & Systems

• 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.

• 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.

• 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.