Remote Central Monitor II – Clinical Trials (Mexico)

Syneos Health; Mexico; On-site; PHP 2,212,000 - 3,317,000; Full time

Job summary

Syneos Health in Mexico is seeking a Central Monitor II to perform remote patient data review for Phase I-IV studies, ensuring protocol adherence, ICH-GCP compliance, and data integrity using diverse technologies.

The CM II will review data listings and dashboards to confirm eligibility, identify deviations, and escalate safety issues with project team guidance. Knowledge of GCP, strong analytics, and 10% travel required.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Mastery of MS Excel (sorting, filtering, calculating, pivoting).
• Proficient with Analytical Data Visualization Tools (adjusting visualizations, selecting subsets of data to analyze).
• Excellent verbal and written communication skills to relate to internal stakeholders. Able to inform, influence and communicate cross-functionally.
• Strong analytical skills.
• Developing therapeutic expertise.
• 10% travel (limited to trainings, investigator meetings)

Responsibilities

• Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.
• Reviews patient data listings and visualizations via analytical dashboards and/or reports to confirm eligibility, identify protocol deviations, patient safety concerns, data integrity issues and illogical/inaccurate/missing data.
• Assess factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Immediately communicates/escalates serious issues to the project team and with guidance develops action plans.
• Documents observations noted during reviews and writes queries, protocol deviations or action items as necessary in appropriate systems for action by sites, CRAs or other functional team members.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Accesses vendor systems or reports to verify the IP has been dispensed and administered to subjects/patients according to the protocol, that laboratory and other procedures have been performed, that eTMF data is current and complete.
• Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan.
• For assigned activities, understands project scope, budgets, and timelines; manages patient- and site-level activities to ensure project objectives, deliverables and timelines are met.
• Must be able to quickly adapt, with the oversight of the Lead CRA/LCMDA, to changing priorities to achieve goals/targets.
• Prepares for and attends Investigator Meetings and/or sponsor meetings. Participates in project staff meetings, as applicable and attends clinical training sessions according to the project specific requirements.

Skills

MS Excel

Analytical Data Visualization Tools

Good Clinical Practice/ICH E6 (R2)

Strong analytical skills

Excellent verbal and written comms

Developing therapeutic expertise

Education

Bachelor’s degree

RN

Tools

Analytical Data Visualization Tools

Job description

Syneos Health in Mexico is seeking a Central Monitor II to perform remote patient data review for Phase I-IV studies, ensuring protocol adherence, ICH-GCP compliance, and data integrity using diverse technologies.

The CM II will review data listings and dashboards to confirm eligibility, identify deviations, and escalate safety issues with project team guidance. Knowledge of GCP, strong analytics, and 10% travel required.