A Top-Tier Global Pharma Leader is seeking a hands-on Sr. Manager, Interactive Response Technology for a 100% remote contract position. This individual contributor role carries end-to-end responsibility for the design, build, implementation, and lifecycle management of IRT/RTSM platforms across Phase I-IV clinical trials, serving as the functional bridge between Clinical Supply Chain, Operations, and IT.
location: Telecommute
job type: Contract
salary: $70.00 - 79.31 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Lead end-to-end study-level IRT builds from protocol kickoff to decommissioning, managing vendors to critical timelines.
- Translate protocols into User Requirement Specifications (URS) covering randomization design, dosing regimens, unblinding rules, and resupply configuration.
- Orchestrate cross-functional User Acceptance Testing (UAT), test plan development, and defect resolution prior to go-live.
- Provide operational oversight during conduct, continuously refining resupply parameters to prevent stock-outs and minimize drug wastage.
- Oversee mid-study protocol amendments through formal change control, specifications updates, and re-testing.
- Own organizational IRT standards, SOPs, governance, and vendor KPI performance reviews to scale capabilities.
qualifications:
Required:
- Bachelor's degree in life sciences, engineering, supply chain, or information systems.
- 5+ years in clinical supply chain, clinical operations, or clinical systems, including 5+ years of hands-on IRT/RTSM study ownership.
- Demonstrated experience with complete IRT builds (URS authoring, UAT leadership, go-live, change control, and close-out).
- Deep understanding of GCP, 21 CFR Part 11, computer system validation, and randomization/blinding methodologies.
- Proven track record managing external IRT vendors across concurrent trials and global time zones.
- Experience with multiple commercial IRT/RTSM platforms.
- Exposure to rare disease, gene therapy, direct-to-patient supply, or decentralized trial models.
skills: ERP System, Clinical Trial Management Systems (CTMS), Interactive Response Technology (IRT)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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