Senior Manager, Clinical Systems

New

Skills

Agile Project Management Clinical Systems Management Clinical System Validation CTMS Management eCOA Implementation IRT Implementation Site Portals Development SOP Compliance Veeva Vault Waterfall Project Management

The Senior Manager of Clinical Systems will provide Subject Matter Expert (SME) guidance on clinical system operations across study teams and vendors. This role involves leading end-to-end clinical system programs, managing projects, and ensuring compliance with established standards.

Key Responsibilities
  • Provide SME guidance on clinical system operations.
  • Lead end-to-end clinical system programs including scope, planning, timelines, resources, and execution.
  • Manage insourced and outsourced clinical system projects such as IRT, site portals, CTMS, and eCOA.
  • Establish governance including risk management, issues, dependencies, and executive status reporting.
  • Collaborate with IT, QA, and Clinical System Validation teams for implementation and lifecycle management.
  • Ensure compliance with SOPs, GDocP, ALCOA-CCEA, and GCP, while managing changes.
Requirements & Qualifications
  • Bachelor’s degree or higher or equivalent experience.
  • 10+ years managing clinical system activities in biotech or pharma.
  • Experience implementing eCOA, IRT, eTMF, CTMS, and LMS.
  • Veeva Vault experience preferred.
  • Experience with validation, SOPs, and integration of clinical systems.
  • Proficiency in PM methodologies (Agile/Waterfall/hybrid) and PM tools (Smartsheet, MS Project).

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Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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