2 дня назад
Project Manager - IRT
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Project Manager - IRT (Clinical Research/IRT): Leading the requirements, development, validation, and implementation of interactive response technology systems for clinical studies with an accent on randomization, clinical supply, eCOA components, and regulatory compliance. Focus on managing client-facing projects, coordinating software development lifecycles, overseeing UAT, and delivering end-user training.
Location: Remote within the United Kingdom
Company
supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics.
What you will do
- Analyze clinical study protocols, including randomization, supply, and eCOA requirements.
- Lead requirements gathering with clinical study teams and sponsors.
- Oversee the development and validation of assigned IRT systems and applicable eCOA components.
- Manage client meetings, project timelines, budgets, and activities across the software development lifecycle.
- Implement software changes, oversee User Acceptance Testing, and coordinate end-user training.
- Coordinate with license and copyright holders on eCOA implementation and usage agreements.
Requirements
- Bachelor’s degree or international equivalent, or equivalent experience in IRT technology.
- 3–5 years of client-facing IRT project management experience.
- Knowledge of randomization methodologies and clinical supply strategies.
- Understanding of computerized information systems, the software development lifecycle, data structures, and query languages.
- Relevant medicine, science, pharmaceutical, or clinical research experience.
- Knowledge of ICH/GCP regulations, FDA guidance documents, EU directives, and Microsoft Office tools including Word, Excel, Visio, and PowerPoint.
Culture & Benefits
- Remote full-time work within the United Kingdom.
- Flexible working arrangements intended to support work-life balance.
- Opportunities for professional growth, skills development, and career progression.
- Team members are encouraged to influence working practices and contribute ideas.
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