IRT Project Manager - Driving Life-Saving Clinical Tech

41 Premier Research Group Limited

United Kingdom

On-site

GBP 65,000 - 90,000

Full time

3 days ago

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Job summary

Premier Research is seeking a Project Manager for Interactive Response Technology (IRT) to join our IRT team. You will analyze study protocols, gather system requirements, and oversee development and validation of IRT systems including eCOA components.

You will lead client meetings, manage timelines and budgets through the SDLC, and coordinate licensing with rights holders as applicable. A background in life sciences and pharma clinical research is essential.

Qualifications

Bachelor's degree or international equivalent in a relevant field
3–5 years' client-facing IRT PM experience
Knowledge of randomization methodologies and supply strategies
Understanding of computerized information systems and the SDLC
Background in medicine or life sciences and pharma/clinical research
Familiarity with ICH/GCP, FDA guidance, and EU directives
Experience with eCOA essential for this role
Strong IRT design experience

Responsibilities

Analyze the study protocol to understand study needs, including randomization, supply, and eCOA requirements where applicable
Lead and facilitate system requirements gathering with clinical study teams and sponsors
Oversee the successful development and validation of assigned IRT systems, including eCOA components where in scope
Lead client meetings for assigned projects and manage project timelines, budgets, and related activities throughout the software development lifecycle
Implement software changes or suggest necessary improvements to system operations and specifications
Oversee User Acceptance Testing (UAT)
Coordinate with license holders/copyright holders on eCOA implementation to support licensing and usage agreements where applicable