Remote CTM I — Clinical Monitoring Specialist (CDMX)

Syneos Health, Inc.; Ciudad de México; Hybrid; MXN 480,000 - 600,000; Full time

Job summary

Syneos Health is seeking a Clinical Monitoring/Site Management professional for CDMX with remote capabilities. You will conduct site qualification, initiation, interim monitoring, site management, and close-out visits, ensuring regulatory compliance and data integrity.

Responsibilities include source document review, IP inventory, ISF/TMF reconciliation, data entry, and collaboration with the Lead CRA to adapt to changing priorities within timelines and SOPs.

Responsibilities

• Performs site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remote) ensuring GCP/GPP and protocol compliance.
• Verifies informed consent is obtained and documented; protects confidentiality; assesses factors affecting subject safety and data integrity.
• For the CMP/SMP: Assesses site processes
• Conducts Source Document Review of site source documents and medical records
• Verifies required clinical data entered in the CRF is accurate and complete
• Applies query resolution techniques remotely and on site; drives closure within timelines
• Utilizes hardware and software to support the conduct of the clinical project data review and capture
• Verifies site compliance with electronic data capture requirements
• May perform IP inventory, reconciliation, storage checks; ensure IP dispensing per protocol; manage IP labeling and release
• Reviews ISF for accuracy; reconciles with TMF; ensures archiving of essential documents per guidelines
• Documents activities via letters, trip reports, logs; supports recruitment and retention; enters data into tracking systems
• Understands project scope, budgets, and timelines; manages site activities and communication; adapts with Lead CRA to changing priorities
• May act as primary liaison with project site personnel

Job description

Syneos Health is seeking a Clinical Monitoring/Site Management professional for CDMX with remote capabilities. You will conduct site qualification, initiation, interim monitoring, site management, and close-out visits, ensuring regulatory compliance and data integrity.

Responsibilities include source document review, IP inventory, ISF/TMF reconciliation, data entry, and collaboration with the Lead CRA to adapt to changing priorities within timelines and SOPs.