5 дней назад
Clinical Project Manager (Oncology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Project Manager (Oncology): Leading local study teams and delivering country-level clinical trial commitments across resources, budgets, timelines, and quality requirements with an accent on oncology or respiratory studies, Phase III trials, and ICH-GCP compliance. Focus on coordinating site selection and activation, regulatory submissions, monitoring activities, study documentation, budgets, and resolution of complex operational risks.
Location: Kyiv, Ukraine. Candidates must be based in the listed location; national and international travel may be required.
Company
IQVIA 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 at country level.
- Manage country-level study commitments, timelines, budgets, quality, and delivery of clinical data.
- Coordinate site identification, qualification, initiation, monitoring, closure, and document archiving.
- Manage regulatory, ethics committee, informed consent, financial agreement, and essential document activities.
- Oversee local drug activities, CTMS setup, monitoring plans, and study closure processes.
- Identify study risks, resolve complex issues, and organize regular Local Study Team meetings.
Requirements
- Bachelor’s degree in a related discipline, preferably life sciences, or equivalent qualification.
- At least one year of local Clinical Project Management experience.
- Very good knowledge of oncology or respiratory therapeutic areas and experience with Phase III clinical trials.
- Strong clinical study process, monitoring, project management, prioritization, negotiation, and cross-functional leadership skills.
- Very good spoken and written English and Ukrainian are required.
- Ability to learn and use IT systems and travel nationally and internationally as required.
Culture & Benefits
- Work on clinical research programs supporting the development of innovative medical treatments.
- Operate within sponsor procedures, ICH-GCP guidelines, and applicable local regulations.
- Collaborate with cross-functional clinical, regulatory, and site teams.
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