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Clinical Operation Manager

Chiltern

Madrid, Spain

JOB BACKGROUND

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.

REQUIREMENTS

  • 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.

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