Clinical Operation Manager
The Chiltern Source department is currently looking for a Clinical Operation Manager to work office based in Madrid.
The Clinical Operation Manager will be accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
DUTIES & RESPONSIBILITIES
- Ownership of country and site budgets;
- Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols;
- Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments;
- Works in close collaboration internally with the clinical team country operations;
- Finance, Medical Affairs, Regulatory Affairs, PV, Business Compliance, Legal and regional operations and externally with vendors and sites and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets;
- Oversight and coordination of local processes.
- At least 5 years experience in a similar role and background in clinical research;
- Good knowledge of ICH/GCP and country regulations;
- Excellent communication, educational/pedagogic, interaction, collaboration and organizational skills;
- Fluency in English is required.