Manages IRT and eCOA systems for clinical studies, including protocol analysis, requirements gathering, system development and validation, client meetings, timelines, budgets, software changes, UAT, user training, and licensing coordination. The role requires knowledge of randomization, clinical supply strategies, SDLC, data structures, query language, pharmaceutical research, and applicable ICH, GCP, FDA, and EU regulations.
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
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