Project Manager

Hace 2 días

Zaragoza, Aragón, España Premier Research Jornada completa

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Overview In 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 / Beneficios
* flexible work arrangements
* growth opportunities
* work-life balance Responsabilidades
* Analyze 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 principales
* Bachelor’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

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