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Senior Clinical Data Manager

1 month ago

Redwood City CA, United States Planet Pharma Full time

The Opportunity:

The Senior Clinical Data Manager is responsible for all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), routine data review through database lock of clinical trials.  The Sr/CDM has a broad, fundamental knowledge of the data management process and can plan, manage and coordinate all Data Management activities for assigned study(ies) with minimal guidance. This person may have project level oversight of junior data managers and/or Clinical Data Associates (CDAs).  The core duties and responsibilities of the Sr/CDM are delineated below. Specifically, you will be responsible for:

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 the development of programming specifications and the creation of program-specific validation plans using established validation practices and processes.Provide robust technical SAS programming expertise to support data management, including the development, validation, implementation, and maintenance of data review listings, metrics, dashboards, and reconciliation reports for all studies.Work experience in using CRF-Annotation, FDA regulations such as CDISC, 21 CFR Part 11, ICH, GCP guidelines, and other regulatory submissions to the NDA.Participate in the development and implementation of 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 participate in modifying existing SAS macro programs to improve efficiency throughout the project life cycle.

Required Experience, Skills, and Education:

MS, BS/BA degree or other suitable qualification with relevance to the field.Custom reporting using Business Objects, SAS, Python, Crystal Reports, and understanding of Medidata Rave Study Build is required.Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.Should have real-time 6+ years of work experience in Phases I, II, and III oncology clinical trial studies.Quick learner, self-starter, effective troubleshooter, and good at resolving data issues, committed to continuous learning and improvement, and should be a team player.Effective written and oral communication skills required.

Preferred Skills:

Possessing SAS certification, work experience in Spotfire or Tableau or Power BI and windows batch script is preferred.