Global Clinical Monitor & Site Leader (Remote)

Syneos Health, Inc.; España; On-site; EUR 42,000 - 66,000; Full time

Job summary

Syneos Health is seeking a Clinical Monitoring/CRA professional to support site qualification, initiation, and ongoing monitoring activities across multiple sites. The role involves on-site or remote visits, ensuring ICH-GCP and local regulatory compliance, and maintaining high data integrity for clinical trials.

The position requires review of consent processes, management of source documents, and collaboration with site teams to address issues, with a focus on timely data capture and adherence

Responsibilities

• Performs site qualification, initiation, interim monitoring, site management activities and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
• Verifies informed consent process has been adequately performed and documented for each subject; protects confidentiality and assesses safety/data integrity factors at sites.
• For the CMP/SMP: Assesses site processes.
• Conducts Source Document Review of appropriate site source documents and medical records.
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
• Applies query resolution techniques remotely and on site to drive closure within timelines.
• Utilizes hardware and software to support project data review and capture.
• Verifies site compliance with electronic data capture requirements.
• May perform IP inventory, reconciliation and reviews storage/security; ensures IP labeling/import/release per protocol.
• Routinely reviews ISF for accuracy, timeliness and completeness; reconciles with TMF.
• Documents activities via letters, logs, trip reports; supports recruitment and tracking observations.
• Understands project scope, budgets, and timelines; manages site-level communication to meet objectives; adapts to changing priorities under guidance.
• Acts as primary liaison with project site personnel; ensures training/compliance of site team.
• Prepares for Investigator Meetings and sponsor meetings; participates in global clinical monitoring/project staff meetings.

Job description

Syneos Health is seeking a Clinical Monitoring/CRA professional to support site qualification, initiation, and ongoing monitoring activities across multiple sites. The role involves on-site or remote visits, ensuring ICH-GCP and local regulatory compliance, and maintaining high data integrity for clinical trials.

The position requires review of consent processes, management of source documents, and collaboration with site teams to address issues, with a focus on timely data capture and adherence