Sumitomo Pharma America, Inc.
We are united in our mission to deliver patient-needed therapies sooner.
IRT Manager
Location
United States
Posted
59 days ago
Salary
$134K - $167.5K / year
Bachelor Degree5 yrs expEnglish
Job Description
• Provide portfolio-level oversight of RTSM/IRT deployments
• Act as primary vendor manager for IRT providers
• Plan, execute, and deliver RTSM/IRT projects
• Lead design and development of User Requirement Specification (URS)
• Track operational health and manage the full RTSM/IRT lifecycle
• Partner with Data Management analytics platforms
• Provide guidance on system design alternatives
• Serve as the main contact for regulatory inspection activities
Job Requirements
- Bachelor's degree in Life Sciences, Engineering, Data/Information Science, or related discipline
- 5–8 years in clinical development
- 3+ years hands-on IRT/RTSM leadership
- Strong understanding of subject randomization methods
- Familiarity with vendor management and industry best practices
- Working knowledge of ICH E6 (R2/R3), CSV/validation, data privacy, and GxP expectations
- Experience with 4G/endpoint (or equivalent IRT) and integrations into common EDCs/CTMS
- Oncology experience; adaptive or complex designs
Benefits
- 401(k) plan
- medical insurance
- dental insurance
- vision insurance
- life insurance
- disability insurance
- flexible paid time off
- 11 paid holidays
- additional time off during December shut-down
- 80 hours of paid sick time upon hire and each year thereafter
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