IRT Project Lead – Life Sciences & eCOA Systems

Premierresearch; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

Premier Research is seeking a Project Manager for Interactive Response Technology (IRT) to lead system design, requirements gathering, and lifecycle management for IRT solutions in biotech, medtech, and pharma projects.

The role focuses on client-facing project leadership, SDLC adherence, and collaboration with sponsors to ensure successful software deployment and licensing support in a fast-paced life sciences environment.

Qualifications

• Bachelor’s degree or international equivalent; IRT field experience.
• 3–5 years of client-facing IRT project management.
• Knowledge of randomization methodologies and supply strategies.
• Understanding of SDLC in computerized information systems.
• Background in medicine, science, or related pharmaceutical/clinical research.
• Familiarity with ICH/GCP, FDA guidance, and EU directives.
• Proficiency with eCOA electronic clinical outcome assessment.
• Strong IRT software 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.

Job description

Premier Research is seeking a Project Manager for Interactive Response Technology (IRT) to lead system design, requirements gathering, and lifecycle management for IRT solutions in biotech, medtech, and pharma projects.

The role focuses on client-facing project leadership, SDLC adherence, and collaboration with sponsors to ensure successful software deployment and licensing support in a fast-paced life sciences environment.