Clinical Data Manager - Katalyst Healthcares & Life Sciences

Responsibilities:

• Collaborate with data managers, statistical programmers, biostatistics, clinical operations, and external vendors to review, sign off on the data transfer specifications, and transfer data from external sources, ensuring data is received and validated for data integrity.
• Collaborate in developing programming specifications and creating program-specific validation plans using established validation practices and processes.
• Provide robust technical SAS programming expertise to support data management, including developing, validating, implementing, and maintaining data review listings, metrics, dashboards, and reconciliation reports for all studies.
• Participate in developing and implementing 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.

• 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 is crucial.

• Quick learner, self-starter, effective troubleshooter, and good at resolving data issues; committed to continuous learning and improvement.

• SAS certification and work experience in Spotfire, Tableau, PowerBI, and Windows batch script are preferred.