1 месяц назад
Clinical Project Manager (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Project Manager (Clinical Research): Manage the full lifecycle of local and international clinical studies with an accent on timelines, budgets, vendor management, and regulatory compliance. Focus on leading study teams, overseeing site operations, identifying risks, and ensuring quality documentation.
Company
International CRO with 25 years of experience in Phase I-IV drug trials and medical devices studies, offering full clinical research services worldwide.
What you will do
- Lead study teams, organize kick-off meetings, and serve as primary contact for Sponsors and Investigators.
- Manage trial timelines, budgets, vendor deliverables, IMP/MD supplies, and study materials.
- Ensure compliance by filing documentation in TMF/eTMF and reviewing site reports against the Monitoring Plan.
- Oversee site feasibility, qualification, and conduct site visits (SIV, MV, COV) or co-monitoring as needed.
- Proactively identify risks and implement solutions to maintain enrollment and milestones.
- Forecast resources, review invoices, and track billable activities.
Requirements
- University degree in a scientific field.
- Minimum 2 years experience as a Clinical Research Associate (CRA); project coordination experience highly valued.
- Excellent knowledge of ICH-GCP and ISO 14155 standards.
- Strong resource management and coordination skills for CRAs and study staff.
- Fluent in English (written and verbal) for updates to international stakeholders.
- Willingness to perform on-site monitoring visits as backup or for quality oversight when required.
Culture & Benefits
- Competitive salary with benefits and bonuses.
- Opportunity for professional career development in a growing company.
- Collaborative international team encouraging initiative and growth.
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