Regional Clinical Compliance Manager
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Job Description
Regional Clinical Compliance Country Manager overseeing clinical trial compliance in Spain. Engaging stakeholders while ensuring adherence to Good Clinical Practice and regulatory requirements.
Responsibilities:
- Ensure robust oversight of clinical trial compliance at the country and site level
- Apply a risk-based approach to proactively identify, evaluate, and manage compliance risks
- Serve as the primary point of contact for country teams regarding GCP requirements and company procedures
- Analyze and confirm initial country and site-specific risks and identify high-risk sites
- Conduct Site Compliance Visits on identified high-risk sites
- Support country teams in identifying, managing, and resolving compliance issues
- Support and manage individual Corrective and Preventive Actions (CAPAs)
Requirements:
- Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline
- Minimum of 5 years of progressive experience in clinical operations roles
- Minimum 4 years’ experience in a GCP compliance or equivalent role
- Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelines
- Analytical and problem-solving skills
- High attention to detail and quality orientation
- Excellent English and Spanish written and verbal communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multitask
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Benefits:
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development opportunities
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