Clinical Operations Systems Steward Lead
Zurich, Zurich
vor 1 Tg.

Position Summary

The Clinical Operations Systems Steward Lead takes a leadership role in the management of Alexion clinical systems including eTMF, CTMS, and eArchive.

Ensures integrity and consistency of clinical system data through data stewardship activities and management of integrations between multiple internal and external systems.

Supports system configuration and upgrade activities. Provides subject matter expertise and support for clinical system end users.

Job Duties & Responsibilities

  • Provide stewardship of eTMF, CTMS, and eArchive systems and associated data and content to ensure these systems serve as reliable information sources, supporting ongoing clinical development activities and health authority inspection
  • Manage reference data sets to ensure consistency across studies and systems
  • Provide systems expertise to business process development efforts
  • Liase with clinical study teams and vendors to ensure accuracy of data in clinical systems
  • Support system configuration activities, system upgrade rollout, and integrations with other internal and external systems
  • Supports data and content migration activities resulting from acquisitions, partnerships, and legacy system migrations
  • Provide subject matter expertise and Tier 1 support for clinical system end users
  • May lead data integration and data review projects and represent Clinical Operations System Integrity team at cross functional meetings
  • Essential Qualifications

  • 3+ years experience with clinical development processes and associated systems
  • Demonstrated critical thinking capabilities with forward looking perspective and comfort with ambiguity
  • Strong verbal, written, and organizational skills with a team-oriented approach
  • Familiarity with MS Office software including : Word, Excel, Outlook, Visio, Project and PowerPoint
  • Preferred Qualifications

  • Hands on experience or certification with Veeva Vault products highly desirable
  • 2+ years eTMF experience desirable
  • 2+ years experience working with CTMS systems desirable
  • Experience with system validation, implementation, and integrations desirable
  • Bachelor’s degree or equivalent in one of the disciplines related to clinical practice / health care, life sciences, or drug development is desirable
  • Experience working in clinical research / medical environment, including exposure to medical or regulatory records and associated systems highly desired
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