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Clinical Systems Manager

Remote, CA

Posted: 04/17/2025 Employment Type: Contract Job Category: Operations and Development Job Number: 4356

Job Description

Responsibilities:
  • Accountable for quality delivery and competencies within the eCOA service area
  • Oversee study level system requirements meetings with eCOA vendors and internal stakeholders
  • Assist in the design and development of study specific technical documents
  • Support the internal team in managing project related timelines and associated activities
  • Partner with data management (DM) to define the requirements for data transfers
  • Work with external resources to manage the creation and execution of user acceptance tests
  • Identify and track study-related technical issues to resolution
  • Provide a supportive framework for continuous process and quality improvements
Basic Qualifications:
  • Doctorate Degree OR
  • Master's Degree and 3 years of Clinical experience OR
  • Bachelor's Degree and 5 years of Clinical experience OR
  • Associate degree and 10 years of Clinical experience OR
  • High school diploma/GED and 12 years of Clinical experience
Preferred Qualifications:
  • Bachelor’s Degree in life science, computer science, engineering, business or related discipline
  • 4+ years of experience in clinical development
  • Experience implementing clinical systems, such as CTMS, EDC, IVRS, ePRO or other related technology in the pharmaceutical/biotechnology industry
  • Knowledgeable in Good Clinical Practices, and FDA regulations necessary
  • Project management and technical expertise, attention to detail, and excellent documentation and communication skills
  • PMP
  • Previous vendor management experience
  • Excellent time management and organization skills
  • Have sound problem resolution, judgment, and decision-making abilities
  • Be able to work well in a team-based environment with minimal supervision
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