Senior Data Standards Expert All Genders

Job description

Your role: In your role as Senior Data Standards Expert / CRF Designer (all genders), you will shape and maintain clinical data standards and design high-quality electronic case report forms for global clinical studies. You will lead complex study builds in electronic data capture systems, manage metadata and standards libraries, and ensure alignment with CDISC, CDASH and SDTM requirements. You will oversee standards deliverables from external partners, support submission readiness, manage study-level standards exceptions, and apply quality-by-design principles. Working across clinical data management, programming, regulatory and technology teams, you will mentor colleagues and drive improvements in standards governance, automation and emerging data formats. This role requires to be on-site in our office in Warsaw, Poland for 3 days per week. Who you are: Advanced degree in life sciences, computer science or equivalent experience 6 - 8 years in clinical data standards, data management or eDC design Strong CDISC, CDASH, SDTM, metadata and CRF design expertise Experience leading complex studies and cross-functional projects Knowledge of regulatory submissions and validation tools Clear communication, problem-solving and mentoring skills YOUR MAIN BENEFITS: Health and well-being: Get access to private medical care, life insurance, and sports card, receive prepaid lunch card Work-Life balance: Enjoy additional paid days off, flexible working hours. Learning and Development: Take advantage of co-financing for language courses, trainings, and certifications as well as other development opportunities Employee support and engagement: Benefit from Employee Assistance Program and join employee engagement groups for support and connection. Information on how we process your personal data for recruitment purposes, you can find on the registration form in our Recruitment Portal.