Clinical Data Manager
Clinical Data Manager
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1 Vacancy
Job Description
- 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.
Employment Type
Full Time
