2 дня назад
Project Manager - Interactive Response Technology (IRT)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Project Manager - Interactive Response Technology (IRT): Leading the design, development, validation, and implementation of IRT systems for clinical studies with an accent on randomization, supply strategies, and eCOA/ePRO requirements. Focus on gathering system requirements, managing timelines and budgets, coordinating client meetings and licensing, and overseeing User Acceptance Testing.
Location: Remote from Spain
Company
supports biotech, medtech, and specialty pharmaceutical organizations in developing medicines, medical devices, and diagnostics.
What you will do
- Analyze clinical study protocols, including randomization, supply, and eCOA requirements.
- Lead requirements-gathering sessions with clinical study teams and sponsors.
- Oversee the design, development, validation, and implementation of assigned IRT systems.
- Manage client meetings, project timelines, budgets, and activities across the software development lifecycle.
- Coordinate software changes, system improvements, and User Acceptance Testing.
- Coordinate eCOA licensing and usage agreements with relevant rights holders.
Requirements
- Bachelor’s degree or equivalent experience in IRT technology.
- 3–5 years of client-facing IRT project management experience.
- Essential: strong experience with eCOA, including ePRO and electronic patient-reported outcomes.
- Strong IRT system design experience is required.
- Knowledge of randomization methodologies, supply strategies, computerized information systems, and the software development lifecycle.
- Background in medicine, science, pharmaceuticals, or clinical research, with knowledge of ICH/GCP regulations, FDA guidance documents, and EU directives.
Culture & Benefits
- Remote work with flexibility and work-life balance.
- Opportunities to develop skills and advance professionally.
- Work connected to medical innovation and the development of medicines, devices, and diagnostics.
- Employee ideas and input influence how work is performed.
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