Added
27 minutes ago
Location
Type
Full time
Salary
Salary not provided
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Related skills

gcp edc ctms capa ixrs

📋 Description

  • Support the Quality Management System (SOPs, training, CAPA)
  • Manage documentation for controlled documents
  • Develop and administer training for employees/consultants
  • Host client/sponsor audits and support regulatory inspections
  • Coordinate vendor, internal, site audits and TMF audits
  • Support computer systems validation and change control processes

🎯 Requirements

  • Extensive GCP process audit experience
  • GCP/ICH guidelines and FDA regulations knowledge
  • Bachelor’s degree in science/healthcare or related field
  • Travel up to 25% domestically and internationally
  • CRO experience preferred
  • Experience with electronic trial systems (EDC, CTMS, IxRS)
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