Clinical Trial Manager – Future Roles

About the role

Syneos Health is seeking a Clinical Trial Manager to support future real‑world late‑phase studies in Serbia. The role involves overseeing site qualification, initiation, monitoring, and close‑out activities while ensuring compliance with ICH‑GCP, regulatory requirements, and study protocols.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, and close‑out visits (on‑site or remotely) ensuring regulatory and protocol compliance.
• Review source documents, verify data entered in case report forms, and resolve queries within agreed timelines.
• Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
• Maintain Investigator Site Files, reconcile with Trial Master Files, and ensure proper archiving of essential documents.
• Document activities through letters, trip reports, and logs; support recruitment, retention, and patient awareness strategies.
• Collaborate with project teams, sponsor affiliates, and local staff; act as liaison for site personnel.

Required profile

• Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
• Knowledge of Good Clinical Practice, ICH Guidelines, and applicable regulatory requirements.
• Excellent communication, presentation, and interpersonal skills.
• Willingness to travel up to 75% of the time.

Required skills

• Good Clinical Practice (GCP) and ICH‑GCP compliance.
• Electronic Data Capture (EDC) systems and query resolution techniques.
• Source document review and data verification.
• Investigational product handling, inventory, and reconciliation.
• Proficiency with computer applications and new technologies.