13 дней назад
Local Clinical Project Manager (Sponsor Dedicated)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Local Clinical Project Manager (Sponsor Dedicated) (Clinical Trials): Leading country-level study teams and delivering clinical trial commitments in compliance with ICH-GCP, sponsor procedures, and local regulations with an accent on site selection, regulatory submissions, monitoring, and study budgets. Focus on coordinating Phase III trials, managing country and site risks, and ensuring timely, high-quality delivery across cardiovascular, renal, metabolic, respiratory, and immunology studies.
Location: Illkirch-Graffenstaden, France; only candidates based in the listed location will be considered.
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 to deliver country-level clinical study commitments on time, within budget, and to the required quality.
- Coordinate feasibility assessments, 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, Master CSAs, and informed consent documentation.
- Coordinate local drug activities, CTMS setup, local websites, and monitoring activities from site activation through study closure.
- Identify study risks, resolve complex issues, review monitoring reports, and conduct co-monitoring or training visits when required.
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 and experience with Phase III clinical trials.
- Knowledge of cardiovascular, renal, metabolic, respiratory, and/or immunology therapeutic areas.
- Strong clinical study process, monitoring, project management, prioritization, negotiation, and cross-functional leadership skills.
- Very good spoken and written English and French are required.
- Ability to learn and use IT systems and travel nationally and internationally as required.
Culture & Benefits
- Work is performed within a global clinical research and healthcare intelligence organization.
- The role supports a flexible capacity model and may include site monitoring responsibilities.
- Work follows sponsor procedures, ICH-GCP guidelines, and applicable local regulations.
- Travel opportunities include national and international clinical study activities.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
