Regional Clinical Compliance Manager

This is a fully remote position, open to applicants in Spain.

📋 Description

• Provide comprehensive oversight of clinical trial compliance at both the country and site levels.

• Utilize a risk-based strategy to proactively identify, assess, and manage compliance risks.

• Act as the main liaison for country teams concerning GCP requirements and company protocols.

• Analyze and validate initial country and site-specific risks while pinpointing high-risk sites.

• Conduct Site Compliance Visits at designated high-risk locations.

• Assist country teams in recognizing, managing, and resolving compliance challenges.

• Oversee and manage individual Corrective and Preventive Actions (CAPAs).

⛳️ Requirements

• A Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical, or healthcare field.

• At least 5 years of progressive experience in clinical operations roles.

• A minimum of 4 years’ experience in a GCP compliance or similar position.

• Familiarity with clinical trial processes, along with a comprehensive understanding of ICH-GCP and related regulatory guidelines.

• Strong analytical and problem-solving abilities.

• Exceptional attention to detail and a focus on quality.

• Proficient written and verbal communication skills in both English and Spanish, along with strong interpersonal abilities.

• Outstanding organizational skills, with the capacity to prioritize and manage multiple tasks.

• Proficient in PC usage; MS Office skills (Outlook, Word, Excel, PowerPoint) are required.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.

• Flexible work arrangements.

• Opportunities for professional development.