Clinical Data Manager

Role Overview

• Review and evaluate clinical data generated from the imaging portion of sponsor clinical trials across various therapeutic areas.
• Perform all data management deliverables for assigned studies, ensuring timelines and quality standards are met.
• Support study setup activities, including eCRF/TF design, database structure, and specifications, obtaining and providing necessary approvals.
• Understand study implementation and data collection requirements and translate these into robust data management plans.
• Collaborate with project teams to develop and maintain study-specific edit check criteria.
• Define, run, and review edit checks, identify discrepant data, and drive timely data query resolution.
• Coordinate, document, and oversee the receipt and processing of electronic or ancillary data from external sources (e.g., central labs, CROs, sponsors).
• Maintain organized, complete, and up-to-date study documentation in accordance with internal and regulatory standards.
• Track outstanding data issues, follow up with stakeholders, and ensure discrepancies are resolved and documented.
• Ensure accuracy and consistency in the manipulation, review, and validation of clinical data, adhering to relevant regulatory guidelines.
• Adhere to Clinical Data Management procedures, policies, and SOPs, and contribute to the review and improvement of departmental standards and processes.
• Collaborate with internal teams to resolve operational issues, share knowledge, and support others in achieving project goals.
• Participate in company-sponsored training to maintain and enhance technical and industry knowledge.

Requirements

• Bachelor’s degree in Computer Science, Life Sciences, or a related field, or equivalent relevant experience.
• Approximately 1+ years of experience in a similar role within the pharmaceutical, biotechnology, or CRO industry.
• Working knowledge of relational database organization and data validation.
• Familiarity with SAS is desirable.
• Experience with office productivity tools such as Word, Excel, and Access.
• Understanding of clinical trial terminology is an advantage.
• Demonstrated problem-solving skills and a proactive, solution-oriented mindset.
• Ability to work independently within a team environment and to adapt to changing priorities.
• Excellent attention to detail with strong documentation and organizational skills.
• Strong interpersonal and communication skills, both verbal and written.
• Ability to project and maintain a professional, positive attitude while working with diverse stakeholders.

Benefits

• Competitive compensation
• Attractive benefits (security, flexibility, support and well-being)
• Engaging employee programs
• Remote working and home office allowance
• OTP Szép Card