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Clinical Systems Manager
Remote, CA US
Posted: 01/16/2025
2025-01-16
2025-02-23
Employment Type:
Contract
Job Category: Clinical Administration
Job Number: 4220
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
- 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
- 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