Clinical Data Manager
2 weeks ago
Job Summary:
We are seeking a highly skilled Clinical Data Manager to join our team at Katalyst Healthcares & Life Sciences. The successful candidate will be responsible for managing and analyzing clinical trial data, ensuring data integrity and quality, and collaborating with cross-functional teams to drive project success.
Responsibilities:
- Collaborate with data managers, statistical programmers, biostatistics, clinical operations, and external vendors to review, sign off on data transfer specifications, and transfer data from external sources, ensuring data is received and validated for data integrity.
- Develop and implement SAS programming standards, SOPs, and work instructions, including program validation and documentation.
- Work with data managers and generate outputs to support data cleaning, enhance data integrity, and ensure timely, targeted, and accurate deliverables.
- Contribute to the development of SAS macro programs and modify existing SAS macro programs to improve efficiency throughout the project life cycle.
Requirements:
- MS, BS/BA degree, or other suitable qualifications relevant to the field.
- 5+ years of work experience in Phases I, II, and III oncology clinical trial studies.
- Work experience using CRF-Annotation, FDA regulations such as CDISC, 21 CFR Part 11, ICH, GCP guidelines, and other regulatory submissions to the NDA.
- Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team.
Preferred Qualifications:
- SAS certification.
- Work experience in Spotfire, Tableau, PowerBI, and Windows batch script.
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