Clinical Data Manager

This is a fully remote position, open to applicants in Hungary.

📋 Description

• Assess and analyze clinical data generated from the imaging segment of sponsor clinical trials across a range of therapeutic areas.

• Execute all data management tasks for assigned studies, ensuring adherence to timelines and quality benchmarks.

• Assist in study setup tasks, including eCRF/TF design, database architecture, and specifications, while obtaining and providing necessary approvals.

• Grasp study implementation and data collection prerequisites, translating these into comprehensive data management strategies.

• Work collaboratively with project teams to establish and maintain study-specific edit check criteria.

• Define, execute, and review edit checks, identify data discrepancies, and facilitate timely resolution of data queries.

• Coordinate, document, and supervise the receipt and processing of electronic or ancillary data from external sources (e.g., central labs, CROs, sponsors).

• Keep organized, complete, and current study documentation in compliance with internal and regulatory standards.

• Monitor outstanding data issues, follow up with stakeholders, and ensure discrepancies are resolved and well-documented.

• Guarantee accuracy and consistency in the manipulation, review, and validation of clinical data, in accordance with relevant regulatory guidelines.

• Comply with Clinical Data Management procedures, policies, and SOPs, and contribute to the evaluation and enhancement of departmental standards and processes.

• Collaborate with internal teams to address operational challenges, share expertise, and assist others in achieving project objectives.

• Take part 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 position within the pharmaceutical, biotechnology, or CRO sectors.

• Proficient understanding of relational database organization and data validation.

• Familiarity with SAS is a plus.

• Experience with office productivity tools such as Word, Excel, and Access.

• Understanding of clinical trial terminology is beneficial.

• Proven problem-solving abilities and a proactive, solution-focused attitude.

• Capable of working independently within a team environment and adapting to shifting priorities.

• Exceptional attention to detail with strong documentation and organizational capabilities.

• Excellent interpersonal and communication skills, both verbal and written.

• Ability to project and maintain a professional, positive demeanor while collaborating 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