Project Manager – Interactive Response Technology

Overview

In this role you will drive the delivery of IRT solutions for biotech, medtech and specialty pharma programs, shaping study design and software validation. You will collaborate with cross-functional teams to translate study needs into robust IRT designs and eCOA elements, manage timelines and budgets, and ensure regulatory alignment. You’ll lead client engagements, oversee UAT, and coordinate licensing aspects to support compliant, high-quality digital trial experiences. This is a mission-driven opportunity to accelerate medical innovation and improve patient outcomes.

Responsibilities

• Analyze study protocols to identify needs for randomization, supply, and eCOA requirements
• Lead requirements gathering with clinical study teams and sponsors
• Oversee development and validation of assigned IRT systems including eCOA components
• Lead client meetings and manage project timelines, budgets, and SDLC activities
• Implement software changes or improvements to system operations and specifications
• Oversee User Acceptance Testing (UAT)
• Coordinate licensing-related activities for eCOA implementations

Key requirements

• 3 to 5 years’ client-facing IRT project management experience
• Knowledge of randomization methodologies and supply strategies
• Understanding of computerized information systems and the SDLC
• Background in medicine, science or related field within pharmaceutical/clinical research
• Understanding of ICH/GCP, FDA guidance, and EU directives
• Must have eCOA experience
• Strong IRT system design experience

• client-facing communication
• stakeholder management
• cross-functional collaboration
• eCOA (Electronic Clinical Outcome Assessment)
• IRT system design
• SDLC knowledge

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