Senior Clinical Data Management Systems Specialist (RAVE) - Remote

Overview

The Senior Clinical Data Systems Specialist provides Data Management Tech Team expertise and support to project teams. The successful candidate will have good knowledge of clinical data management systems, as well as global regulatory and industry rules and guidance (i.e., ICH, GCP). This role is responsible for supporting the Arcus Medidata Rave URL and database build activities. This position may train Clinical Data Management team members and may support activities of Arcus Clinical Data Management staff, CRO and Database Vendors. The incumbent may contribute to department initiatives.

In Short

• Manage administration of the Arcus Rave URL activities.
• Provide technical support for Rave study development.
• Lead development of study database development.
• Support Arcus Global Library by programming forms.
• May support Clinical Data and SAS Programming activities.
• Serve as system administrator for Medidata Cloud Administration.
• Maintain all data management internal files.
• Attend meetings with Arcus and Medidata teams.
• Represent DM Tech Team on cross-functional teams.
• Participate in departmental development initiatives.

Requirements

• Bachelor's Degree with 3 years’ experience in Clinical Data Management.
• Practical knowledge of ICH, FDA, and GCP regulations.
• Proven track record of high-quality Data Management deliverables.
• Highly organized and self-motivated.
• Certified Medidata Study Builder preferred.
• Knowledge of Medidata areas including Cloud Administration.
• Medidata Custom Function programming experience preferred.
• General knowledge of industry standards such as CDISC/CDASH/SDTM.
• Excellent verbal and written communication skills.
• Oncology experience preferred.

Benefits

• Competitive market-based salary.
• Opportunity to participate in stock programs.
• Performance-based bonus.
• Comprehensive benefits package.