13 дней назад
Associate Local Study Project Manager (Clinical Research)
171 500 - 418 600PLN
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Local Study Project Manager (Clinical Research): Leading country-level clinical study teams in Poland and delivering clinical trial commitments with an accent on site selection, regulatory submissions, budgets, monitoring, and ICH-GCP compliance. Focus on coordinating Phase III studies in oncology or respiratory medicine, resolving complex operational risks, and ensuring timely, high-quality trial delivery.
Location: Warsaw, Poland; candidates must be based in the listed location. National and international travel may be required.
Annual base pay range: 171,500.00–418,600.00 PLN.
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Lead local study teams consisting of CRAs and CSAs and oversee country-level delivery of clinical study commitments.
- Coordinate study feasibility, site identification, qualification, activation, monitoring, closure, and essential document archiving.
- Manage submissions to ethics committees, institutional review boards, and regulatory authorities in collaboration with Regulatory Affairs.
- Prepare and maintain country study budgets, financial study management agreements, site contracts, informed consent documents, and translations.
- Oversee local drug activities, CTMS setup, monitoring activities, and study websites required by local regulations.
- Identify and resolve complex study risks, review monitoring reports, and organize local study team meetings.
Requirements
- Bachelor’s degree in a related discipline, preferably life sciences, or an equivalent qualification.
- At least one year of local-level clinical project management experience.
- Very good knowledge of oncology or respiratory therapeutic areas and experience with Phase III clinical trials.
- Experience leading cross-functional teams and delivering clinical trials on time, within budget, and to the required quality standards.
- Excellent understanding of clinical study processes, including monitoring, along with strong project management, prioritization, negotiation, and organizational skills.
- Very good spoken and written English and Polish are required. Ability to work with IT systems and travel nationally and internationally is also required.
Culture & Benefits
- Work on clinical research programs supporting the development and commercialization of medical treatments.
- Employment includes a base pay range and may include incentive plans, bonuses, health and welfare benefits, and other benefits depending on the position.
- Work involves collaboration with local study teams, Regulatory Affairs, sponsors, investigators, and clinical research sites.
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