03 nov
|
Premier Research
|
España
03 nov
Premier Research
España
OverviewIn this role you will drive IRT projects for biotech, medtech and specialty pharma, turning study protocols into validated, compliant systems.
You will collaborate with study teams to gather requirements, oversee development and UAT, and manage timelines and budgets across the software life cycle.
You'll optimize eCOA components and ensure licensing considerations are addressed, delivering robust IRT solutions that support patient-focused trials.
You will work closely with clients and cross-functional teams to shape systems that accelerate medical innovation.
Compensaciones / Beneficiosflexible work arrangements
growth opportunities
work-life balance
ResponsabilidadesAnalyze study protocols to identify study needs (randomization, supply, eCOA)
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 with license/copyright holders on eCOA implementation and licensing needs
Requisitos principalesBachelor's Degree or equivalent experience in IRT technology
3 to 5 years' client-facing IRT Project Management experience
Knowledge of randomization methodologies and supply strategies
Understanding of computerized information systems and the Software Development Life Cycle (SDLC)
Background in medicine/science and pharmaceutical/clinical research industry experience
Understanding of ICH/GCP, FDA Guidance, and EU Directives
Must have eCOA (Electronic Clinical Outcome Assessment) experience
Must have solid IRT system design experience
Experience with ePRO/eCOA components
client-facing communication
cross-functional collaboration
problem solving
IRT system design
eCOA/ePRO/ClinRO knowledge
SDLC understanding
📌 Project Manager (España)
🏢 Premier Research
📍 España