Clin Ops Delivery Associate III, Bucharest, Romania

Clinical operations delivery associate supporting pharmaceutical and biotech clinical trials across multiple countries. Coordinates trial activities, maintains documentation systems, and provides administrative support to project teams while ensuring compliance with regulatory standards and quality requirements.

Responsibilities

• Coordinate and oversee assigned clinical trial activities according to task matrix
• Conduct and document departmental, country, and investigator file reviews
• Maintain study-specific documentation in eTMF and other clinical trial systems
• Process and manage regulatory documents and Investigator Site File materials
• Support RBM activities and assist with site documentation clarification

Requirements

• High school diploma or equivalent; Bachelor's degree preferred
• Minimum 4 years relevant clinical operations or trial coordination experience
• Strong proficiency in MS Office and clinical trial database systems
• Knowledge of ICH Good Clinical Practices and country-specific regulations
• Excellent English language skills; local language proficiency as needed
• Demonstrated organizational skills and attention to detail
• Ability to complete PPD clinical training program