обновлено 4 дня назад
Global Study Manager - Single Sponsor Dedicated (in EMEA)
171 500 - 404 600PLN
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Global Study Manager - Single Sponsor Dedicated (in EMEA) (Clinical Research): Supporting the delivery of clinical studies from protocol development and study set-up through close-out, reporting, and archiving with an accent on cross-functional coordination, CRO oversight, and ICH/GCP compliance. Focus on managing study documents, investigational product and materials, risks and issues, budgets, quality records, and delegated project execution.
Location: Warsaw, Poland; only candidates based in the listed location will be considered
Salary: PLN 171,500–404,600 annualized base pay
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Support clinical study delivery from protocol development and study set-up through maintenance, close-out, clinical study reporting, and archiving.
- Prepare delegated study documents, including informed consent forms, clinical study agreements, specifications, and study procedures.
- Coordinate internal functions, CROs, and external service providers to meet timelines, cost, and quality objectives.
- Coordinate investigator and monitor meetings and ensure the supply of investigational products and study materials.
- Identify risks and issues, develop mitigation plans, and maintain complete, quality-verified documents in the Trial Master File.
- Support budget management, CRO project manager oversight, overall project management, and process improvement initiatives.
Requirements
- University degree or equivalent, preferably in medical or biological sciences or a clinical research-related discipline.
- At least 3 years of relevant pharmaceutical, clinical research, or academic experience preferred.
- Knowledge of clinical and drug development processes across development phases and therapy areas.
- Excellent knowledge of ICH/GCP guidelines and applicable quality and compliance requirements.
- Project management, leadership, collaboration, communication, relationship-building, and external service provider management skills.
- Excellent written and verbal English; candidates must be based in Warsaw, Poland.
Culture & Benefits
- Cross-functional work with client teams, internal functions, CROs, and external service providers.
- Work aligned with international clinical processes, quality standards, and inspection-readiness requirements.
- Health, welfare, and other benefits may be offered in addition to base pay.
- UK visa sponsorship is not available for this role.
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