Note: The job is a remote job and is open to candidates in USA. QualStaff Resources is hiring an Associate Director, Clinical Operations to lead clinical trial execution in a biotechnology and pharmaceutical setting. The role oversees trials from start-up through close-out, manages sites, vendors, budgets, and clinical data systems, and ensures regulatory compliance while collaborating with cross-functional teams.
Responsibilities
- Lead clinical trial activities from start-up to close-out
- Oversee site feasibility, enrollment, and vendor management
- Maintain inspection readiness and regulatory compliance
- Manage budgets, forecasts, and clinical data systems
- Collaborate with cross-functional teams in a fast-growth biotech setting
Skills
- 10+ years of Clinical Operations or Clinical Trial Management experience
- Pharma/biotech experience, CRO backgrounds considered
- Experience managing global, multi-site trials
- Strong understanding of regulatory standards (ICH-GCP, FDA, EMA)
- Inflammatory Bowel Disease (IBD) clinical trial expertise preferred
Benefits
- Flexible/Remote work
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