Senior Clinical Data Manager
W2 Contract
Salary Range: $166,400 - $187,200 per year
Location: Redwood City, CA - Hybrid Role
Job Summary:
As a Senior Clinical Data Manager, you will be responsible for all aspects of the data management process, from developing project documentation, system set-up, User Acceptance Testing (UAT), and routine data review through database lock of clinical trials. We need a candidate with fundamental knowledge of the data management process who can plan, manage, and coordinate all data management activities for assigned study(ies) with minimal guidance.
Duties and 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.
- Ensure quality and timely delivery of clinical trial data in preparation for data review and statistical review.
- Address data issues identified by cross-functional team members.
- Ensure accuracy of clinical trial results for internal and external audiences (e.g., regulatory authorities).
- Contribute to the development of SAS macro programs and modify existing SAS macro programs to improve efficiency throughout the project life cycle.
Requirements and Qualifications:
- MS, BS/BA degree, or other suitable qualifications relevant to the field.
- Custom reporting using SAP Business Objects, SAS, Python, Crystal Reports, and an understanding of Medidata Rave Study Build is required.
- 6+ 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.
- Effective written and oral communication skills required
- SAS certification and work experience in Spotfire, Tableau, PowerBI, and Windows batch script are preferred
Desired Skills and Experience
Clinical Data Management, SAP Business Objects, SAS, Python, Crystal Reports, Medidata Rave Study Build, clinical trial, oncology, CRF-Annotation, FDA, ICH, GCP, New Drug Application, Spotfire, Tableau, PowerBI, Windows batch
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