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
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
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