6 дней назад
R&D - CSU - Clinical Operations Study Country Lead - SH
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
R&D - CSU - Clinical Operations Study Country Lead - SH (Clinical Operations): Leading strategic planning, execution, budgeting, and compliance for assigned clinical trials at the country level with an accent on study start-up, site engagement, performance management, and patient safety. Focus on coordinating local and global stakeholders, mitigating operational and financial risks, and maintaining data quality and regulatory compliance.
Location: Shanghai, China
Company
is a pharmaceutical and healthcare company focused on developing medicines and improving patient outcomes through science.
What you will do
- Develop the local country strategy and lead study start-up activities from country allocation through study closure.
- Plan and manage clinical study execution at the Clinical Study Unit level in line with global and local study plans.
- Lead site mapping, site engagement, recruitment and retention initiatives, and local study team coordination.
- Own country or cluster study budgets, optimize financial resources, and manage budget updates and escalations.
- Coordinate communication among local monitoring teams, medical functions, vendors, and global study stakeholders.
- Monitor study performance, data quality, patient safety, training metrics, audit readiness, and compliance with SOPs, ICH/GCP, and regulatory requirements.
Requirements
- Experience leading or managing clinical studies at the country or Clinical Study Unit level.
- Knowledge of clinical trial operations, study start-up, site engagement, recruitment, and retention processes.
- Ability to manage study budgets, timelines, risks, mitigation plans, and operational escalations.
- Understanding of SOPs, ICH/GCP, regulatory guidelines, data quality, patient safety, and inspection readiness.
- Ability to collaborate with global and local clinical operations, medical, vendor, monitoring, and support functions.
Culture & Benefits
- Full-time employment in a global pharmaceutical and healthcare organization.
- Equal-opportunity workplace committed to diversity, equity, and inclusion.
- Collaboration with colleagues across different locations and functions.
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