Clinical Trial Specialist

Overview

Our organization is seeking a highly skilled Clinical Study Coordinator to oversee the execution and follow-up of clinical trials. The ideal candidate will have experience in international clinical trial coordination and management.

Responsibilities

• Coordinate and ensure proper execution and follow-up of clinical trials, managing vendors to meet timelines, quality standards, and regulatory requirements.
• Develop and manage clinical trial plans, identifying risks and implementing corrective actions.
• Manage site and investigator selection, budget planning, and vendor contracts.
• Evaluate compliance with GCP, FDA, EMA, ICH guidelines, and internal procedures.
• Oversee regulatory documentation and submissions, maintaining audit readiness.
• Supervise clinical trial monitoring, investigational product handling, and patient recruitment strategies.
• Collaborate with pharmacovigilance teams to ensure timely reporting and management of safety events.
• Support quality management through monitoring reports, deviation handling, and protocol amendments.
• Maintain effective communication with internal teams, vendors, investigators, and regulatory authorities.

Essential Skills and Qualifications

Benefits Package

Selection Process

Equal Opportunities Employer

Our organization values diversity and promotes inclusivity for all employees, regardless of background, gender, ethnicity, religion, sexual orientation, disability, or other characteristic.

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