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Clinical Systems Manager
Remote, CA US
Posted: 07/29/2025
2025-07-29
2025-09-14
Employment Type:
Contract
Job Category: Operations and Development
Job Number: 4547
Job Description
The Manager, Clinical Systems (IRT) will work with a cross-functional team of internal stakeholders (including but not limited to: Clinical Study Management, Supply Chain and Data Management functions) and technology suppliers to support the implementation and maintenance of interactive response technology (IRT) solutions to support a clinical trial.
The Manager, Clinical Systems (IRT) will provide technical oversight to ensure that IRT solutions adhere to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.
Responsibilities:
The Manager, Clinical Systems (IRT) will provide technical oversight to ensure that IRT solutions adhere to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.
Responsibilities:
- Serve as the champion and consultant for most efficient and effective IRT design as needed per study protocol
- Lead and facilitate system requirements gathering meetings with clinical study teams and IRT supplier contacts
- Design and oversee the development of study-specific IRT technical documents
- Document issues and risks, and implement mitigation plans in partnership with study team and technology supplier PM
- Identify and track study-related technical issues to resolution
- Closely manage project-related timelines and associated activities
- Doctorate Degree OR
- Master's Degree and 2 years of IRT experience OR
- Bachelor's Degree and 4-5 years of IRT experience, clinical experience OR
- Associate's degree and 10 years of IRT experience OR
- High school diploma/GED and 12 years of IRT experience
- 5+ years focused on IRT experience
- Bachelor’s Degree in life science, computer science, engineering, business or related discipline
- 4+ years of experience in clinical operations, clinical supply chain or clinical systems management
- Experience implementing clinical systems, such as IRT and eCOA
- Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
- Detail-oriented and able to manage many projects simultaneously
- Excellent documentation and communication skills
- Meeting management and facilitation skills
- Vendor management experience
- Excellent time management and organization skills in a timeline-driven environment
- Sound problem resolution, judgment, and decision-making abilities
- Work well in a team-based environment with minimal supervision