Project Manager - Interactive Response Technology

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

Описание:

Premier Research is looking for a Project Manager - Interactive Response Technology to join our Interactive Response Tech (IRT) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.


• Your ideas influence the way we work, and your voice matters here.


• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.


• Join us and build your future here.

Задачи:

• Analyze the study protocol to understand the study needs, including randomization, supply, and eCOA (ePRO/ClinRO) 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.

Требования:

• Bachelor’s Degree or its international equivalent or equivalent experience gained in the IRT technology field.


• 3 to 5 years' client facing IRT Project Management role experience.


• Knowledge of randomization methodologies and supply strategies.


• Understanding of computerized information systems with knowledge of the SDLC (Software Development Life Cycle).


• Background in medicine, science or other relevant discipline and the appropriate experience within the pharmaceutical/clinical research industry.


• Understanding of ICH / GCP regulations, FDA Guidance Documents, and EU Directives.


• Must have eCOA Electronic Clinical Outcome Assessment – Essential to the job responsibilities.


• This role will be Heavily focused on an applicant well versed in IRT software design, rpm is responsible for the design.


• EPRO Electronic patient reported outcome.


• Must have solid IRT Interactive Response Technology System Design experience.