Central Monitor II

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Conducts remote patient data review activities for Phase I-IV clinical trials and/or non-interventional studies (NIS) to evaluate adherence to the protocol, ICH-GCP, and all relevant local and federal regulatory standards.

• Safeguards patient safety and data accuracy utilizing various technological tools.

• Analyzes and comprehends the protocol, critical data and processes, as well as safety and data integrity risks associated with protocol implementation.

• Examines patient data listings and visual representations through analytical dashboards and/or reports to verify eligibility, detect protocol deviations, address patient safety issues, data integrity concerns, and any illogical/inaccurate/missing data.

• Evaluates elements that may impact subject/patient safety and clinical data integrity at an investigator/physician site, including protocol deviations/violations and pharmacovigilance matters.

• Promptly communicates/escalates significant issues to the project team and formulates action plans with guidance.

• Records observations made during reviews and drafts queries, protocol deviations, or action items as necessary in the appropriate systems for follow-up by sites, CRAs, or other functional team members.

• Maintains an up-to-date understanding of ICH/GCP Guidelines or other relevant guidance, applicable regulations, and company SOPs/processes.

• Accesses vendor systems or reports to confirm that the investigational product has been dispensed and administered to subjects/patients in accordance with the protocol, that laboratory and other procedures have been conducted, and that eTMF data is accurate and complete.

• Documents the completion of activities through tracking, reporting, and/or other required project documentation in alignment with SOPs and the Monitoring Plan.

• For designated activities, comprehends project scope, budgets, and timelines; oversees patient- and site-level activities to ensure that project goals, deliverables, and timelines are achieved.

• Prepares for and participates in Investigator Meetings and/or sponsor meetings.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory standards.

• Must exhibit strong computer skills and willingness to adopt new technologies.

• Proficient in MS Excel (sorting, filtering, calculating, pivoting).

• Experienced with Analytical Data Visualization Tools (modifying visualizations, selecting data subsets for analysis).

• Outstanding verbal and written communication skills for engaging with internal stakeholders.

• Strong analytical abilities.

• Developing expertise in therapeutic areas.

• Less than 10% travel (limited to training sessions and investigator meetings).

🏝️ Benefits

• We are dedicated to the growth of our employees, fostering career development and progression.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• We are committed to cultivating an inclusive culture where you can genuinely be yourself.