Project Manager - Interactive Response Technology

46 Premier Research Group SL; España; On-site; EUR 65,000 - 90,000; Full time

Job summary

Premier Research is seeking a Project Manager - Interactive Response Technology (IRT) to join our IRT team. You will drive client-facing projects for biotech, medtech, and pharma sponsors, guiding IRT system design and SDLC activities from kickoff to delivery.

You will oversee study requirements, timelines, budgets, UAT, and licensing considerations, collaborating with sponsors and cross-functional teams to ensure compliant, timely implementations of eCOA components and IRT workflows.

Qualifications

• 3 to 5 years' client facing IRT Project Management role experience.
• Knowledge of randomization methodologies and supply strategies.
• Understanding of ICH / GCP regulations and FDA/EU guidance.

Responsibilities

• Analyze study protocol to understand study needs including randomization and eCOA requirements.
• Lead and facilitate system requirements gathering with clinical study teams and sponsors.
• Oversee development and validation of assigned IRT systems including eCOA components.
• Lead client meetings for assigned projects and manage timelines, budgets, and lifecycle.
• Implement software changes or improvements to system operations and specs.
• Oversee User Acceptance Testing (UAT).
• Coordinate with license/copyright holders on eCOA licensing and usage.

Skills

Project management

Client-facing

SDLC knowledge

eCOA

Education

Bachelor's Degree

Tools

eCOA software experience

Job description

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.

What you'll be doing

• 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 .

What we are looking for

• 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

Premier Research is more than a company - it's a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated.

We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.