Senior Study Operations Lead
Há 7 dias
We are seeking a highly motivated and experienced Regional Clinical Study Manager to lead our regional clinical operations team. The successful candidate will be responsible for delivering high-quality clinical studies within agreed timelines.
- Key Responsibilities:
- Lead the planning and management of assigned clinical studies from feasibility through closeout activities, ensuring effective decision-making and acting as a point of escalation for issue resolution within the region.
- Collaborate with key stakeholders in the region and provide regular updates on study progress to senior management and Global Clinical Study Manager as required.
- Timelines and Planning:
- Generate, manage, and maintain high-quality study start-up and recruitment timelines for the region and track progress towards these.
- Quality Assurance:
- Monitor study activities in the region to ensure compliance with the study protocol, SOPs, ICH/GCP, and all other relevant regulations.
- Resource Management:
- Manage regional study budgets and work closely with Clinical Business Operation on investigator fees, site payment issues, and patient travel reimbursement activities.
Requirements:
- A Bachelor's degree or higher in a scientific or healthcare discipline is preferred with a minimum of 7 years of progressive experience in clinical research within the biotech, pharma, or CRO industry.
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