Clinical Trial Manager I: Site & Data Oversight

Syneos Health; Tewantin; Sur place; AUD 90 000 - 120 000; Plein temps

Résumé du poste

Syneos Health in Australia is seeking a Clinical Research Associate to support site qualification, initiation and monitoring activities across trials. The role emphasizes adherence to ICH-GCP guidelines, accurate data capture, and proactive issue escalation, with substantial travel requirements.

You will ensure site staff training, manage ISF/TMF alignment, and assist in study documentation, sponsor meetings, and audit readiness as part of a dynamic, global team.

Qualifications

• Bachelor’s degree or RN in a related field, or equivalent education/experience.
• Knowledge of Good Clinical Practice/ICH guidelines and regulatory requirements.
• Proficient computer skills; comfortable with data systems and documentation.
• Excellent communication, presentation and interpersonal skills.

Responsabilités

• Performs site qualification, initiation, monitoring, and close-out visits with on-site or remote work, ensuring regulatory and protocol compliance.
• Verifies informed consent, protects confidentiality, and assesses patient safety and data integrity.
• Manages CMP/SMP activities, source data review, CRF accuracy, and query resolution.
• Handles IP inventory/reconciliation and ensures proper labeling and compliance with protocols.
• Maintains Investigator Site Files and TMF alignment, supports recruitment and tracking.
• Prepares for investigator meetings and participates in project-wide communications and trainings.

Connaissances

ICH GCP knowledge

Excellent communication

Good computer skills

Travel up to 75%

Formation

Bachelor’s degree or RN in a related field

Description du poste

Syneos Health in Australia is seeking a Clinical Research Associate to support site qualification, initiation and monitoring activities across trials. The role emphasizes adherence to ICH-GCP guidelines, accurate data capture, and proactive issue escalation, with substantial travel requirements.

You will ensure site staff training, manage ISF/TMF alignment, and assist in study documentation, sponsor meetings, and audit readiness as part of a dynamic, global team.