IRT Project Manager - Life-Saving Biotech Software Lead

Premier Research Group; United Kingdom; On-site; GBP 65,000 - 90,000; Full time

Job summary

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

You will lead client meetings, manage timelines and budgets, and ensure UAT success while coordinating with license holders on eCOA implementations as applicable.

Qualifications

• Bachelor’s degree or equivalent in a relevant field.
• 3–5 years in client-facing IRT project management.
• 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 experience.
• Familiarity with ICH/GCP regulations and FDA/EU guidelines.
• Experience with eCOA and IRT design.

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 development and validation of assigned IRT systems, including eCOA components where in scope.
• Lead client meetings for assigned projects and manage timelines, budgets, and lifecycle activities.
• Implement software changes or suggest improvements to system operations and specifications.
• Oversee User Acceptance Testing (UAT).
• Coordinate with license/copyright holders on eCOA implementation for licensing and usage where applicable.

Skills

Client-facing IRT PM

Randomization knowledge

SDLC understanding

eCOA knowledge

IRT system design

Pharma/clinical research domain

Education

Bachelor’s Degree or international equivalent

Job description

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

You will lead client meetings, manage timelines and budgets, and ensure UAT success while coordinating with license holders on eCOA implementations as applicable.