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
Skills Required
- Bachelor's degree, international equivalent, or equivalent experience in the IRT technology field
- 3 to 5 years of client-facing IRT project management experience
- Knowledge of randomization methodologies and supply strategies
- Understanding of computerized information systems and the Software Development Life Cycle
- Understanding of data structures and query language
- Background in medicine, science, or another relevant discipline with experience in the pharmaceutical or clinical research industry
- Understanding of ICH and GCP regulations, FDA Guidance Documents, and EU Directives
- Knowledge of Microsoft Word, Excel, Visio, and PowerPoint
What We Do
We’re out to change the course of medical science. Are you ready to rise to the challenge? Premier Research is not about being everything to everyone. Instead, our deep, focused expertise targets the therapeutic areas and indications where today’s biotech and specialty pharma pioneers are doing the most amazing work. We’re 1,500 employees strong and operate in more than 20 countries, delivering unmatched expertise, operational skills, and dedication to meeting customers’ most challenging needs. Join us and meet some of the brightest minds in clinical development today — people who apply their best thinking to every project, recognizing that what they do significantly affects the lives and well-being of customers, patients, physicians, and colleagues. You’ll enjoy great benefits and very flexible working conditions in a company that values your contributions, rewards your achievements, and is committed to helping you reach your full potential. Are you ready to make a real difference and help us transform this exciting industry? Follow our company page for more information about us and the work we do, and check out our current openings for your next career move!
