Data Management Systems Expert

1 day ago


Hayward, California, United States Lifelancer Full time

Job Overview

Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, and IT. We are seeking an experienced Clinical Data Management Systems Specialist to join our team.

Estimated Salary: $90,000 - $110,000 per year

Job Description:

The successful candidate will provide clinical database configuration and site/user access management expertise to project teams. A strong knowledge of clinical data management systems, global regulatory and industry rules, and guidance (ICH, GCP) is essential for this role. The incumbent may contribute to department initiatives and additional non-study projects.

Key Responsibilities:

  • Serve as system administrator to grant user access using iMedidata Cloud Administration for RAVE EDC, Coder, Lab Admin, RTSM, and MMI
  • Support administration of the Arcus Rave URL core configurations, including collaboration with Arcus and Medidata teams to identify best practices and implement updates
  • Follow Arcus standard processes and maintain proper documentation during maintenance tasks and implementation of enhancements
  • Provide technical support and troubleshooting for site management and user access within RAVE modules
  • Escalate issues to the Rave Admin and Arcus Support Professional Services teams at Medidata as needed
  • Support RAVE User Role Configuration and perform updates as needed
  • Support Rave Lab Admin configuration as needed
  • Participate in the development of departmental initiatives, such as SOPs, Work Instructions, Guidelines, and templates
  • Maintain all data management internal files, ensuring preparedness for regulatory inspections

Requirements:

  • Bachelor's degree with 2 years' experience in Clinical Data Management or 4 years' equivalent experience in Clinical Data Management with a Pharmaceutical, Biotech, CRO, or Academic Center
  • Practical knowledge of ICH, FDA, and GCP regulations and guidelines
  • Proven track record of on-time and high-quality Data Management deliverables
  • Highly organized, outcome-oriented, and self-motivated performance
  • Ability to adapt to change in a fast-paced work and growth environment
  • Experience with EDC systems, although Medidata products preferred, through full development life cycle
  • General knowledge of industry standards and best practices such as CDISC/CDASH
  • Knowledge of and experience with MedDRA and WHO Drug data dictionaries
  • Familiarity with data integrations in EDC from external data sources
  • Attention to detail and ability to work independently within a multi-disciplinary team

Benefits:

Lifelancer offers a competitive salary, benefits package, and opportunities for professional growth and development.

About Lifelancer

Lifelancer is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to creating an inclusive and diverse workplace where everyone feels valued and respected.



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