Clinical Data Manager

Katalyst CRO; Redwood Terrace (CA); On-site; USD 135,000 - 155,000; Full time

Job summary

A leading biotechnology consulting firm is seeking a Clinical Data Manager in Redwood Terrace. This key position requires extensive collaboration with clinical teams and strong technical expertise in SAS programming to ensure data integrity and compliance in oncology studies. Ideal candidates are experienced, detail-oriented, and ready to contribute to impactful clinical research.

Qualifications

• 5+ years of work experience in oncology clinical trial studies.
• Experience with FDA regulations and CRF-Annotation.
• SAS certification preferred.

Responsibilities

• Collaborate with data teams to ensure data integrity.
• Develop programming specifications and validation plans.
• Generate outputs for data cleaning and integrity.

Skills

Technical SAS programming

Data integrity

Multitasking

Troubleshooting

Continuous learning

Education

MS, BS/BA degree

Tools

SAS

Spotfire

Tableau

PowerBI

Job description

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• 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.
  
  

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.
  
  

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 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Biotechnology Research, Business Consulting and Services, and Hospitals and Health Care

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