Clinical Trial Manager – Future Roles

About the role

Syneos Health is seeking a Clinical Trial Manager for future roles in Serbia. The position involves overseeing site qualification, initiation, monitoring, and close‑out activities while ensuring compliance with regulatory and GCP standards.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, and close‑out visits (on‑site or remote) ensuring regulatory, ICH‑GCP and protocol compliance.
• Evaluate site performance, communicate serious issues, and develop action plans.
• Verify informed consent processes, protect patient confidentiality, and assess safety and data integrity risks.
• Conduct source document review, ensure accurate CRF entry, and resolve queries within timelines.
• Manage investigational product inventory, reconciliation, storage, and dispensing according to protocol.
• Maintain Investigator Site File accuracy, reconcile with Trial Master File, and ensure proper archiving.
• Document activities via letters, trip reports, and logs; support recruitment and retention strategies.
• Coordinate with project teams, attend investigator and sponsor meetings, and contribute to audit readiness.

Required profile

• Bachelor’s degree or RN in a related field, or equivalent education and experience.
• Knowledge of Good Clinical Practice, ICH guidelines, and applicable regulatory requirements.
• Strong computer proficiency and ability to adopt new technologies.
• 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.
• Source document review and medical record verification.
• Electronic Data Capture (EDC) systems usage.
• Investigational product (IP) inventory management and reconciliation.
• Query resolution techniques.
• Regulatory and protocol compliance monitoring.