Clinical Data Manager
Clario
Remote, Hungary
What you'll be doing
- 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.
What we look for
- 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.
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