eCOA & RTSM Application Specialist (Poland)

The eCOA and RTSM Application Specialist is responsible for supporting the design, deployment, configuration, and oversight of electronic Clinical Outcome Assessment (eCOA) solutions—including ePRO, eConsent, and other patient-centric electronic data capture tools— and of Randomization and Trial Supply Management (RTSM) across global clinical studies. This role collaborates with cross-functional teams, Sponsors, and external vendors to ensure that eCOA and RTSM systems are implemented in alignment with study protocols, regulatory requirements, and industry best practices. Key Responsibilities: * Collaborate with clinical study teams and vendors to define eCOA and RTSM system requirements, ensuring they meet study objectives and regulatory guidelines. * Participate in the design and configuration of eCOA and RTSM systems, including user interface (UI) and user experience (UX) considerations. * Manage and maintain eCOA and RTSM system configurations, including user roles, data collection forms, and randomization schedules. * Develop and execute test plans to ensure the quality and accuracy of eCOA and RTSM systems. * Provide ongoing support and troubleshooting for eCOA and RTSM systems during clinical studies. * Monitor system performance and identify opportunities for improvement. * Ensure data integrity and compliance with relevant regulations (e.g., FDA, EMA). * Assist with the development and maintenance of SOPs, training materials, and other documentation related to eCOA and RTSM systems. * Stay up-to-date on industry trends and best practices related to eCOA and RTSM. * May involve travel to client sites and/or vendor locations. Qualifications: * Bachelor's degree in a scientific or related field. * Experience with eCOA and/or RTSM systems. * Knowledge of clinical trial processes and data management. * Understanding of relevant regulations (e.g., 21 CFR Part 11, GDPR). * Excellent communication and interpersonal skills. * Strong analytical and problem-solving abilities. * Ability to work independently and as part of a team. * Proficiency in Microsoft Office Suite. Preferred Qualifications: * Experience with specific eCOA and RTSM platforms (e.g., Medidata, Oracle). * Project management experience. * Experience in the pharmaceutical or biotechnology industry. Benefits: * Competitive salary * Health insurance * Paid time off * Professional development opportunities