Remote Central Monitor II - Clinical Data Review

Syneos Health, Inc.; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

The Central Monitor II role at Syneos Health will perform remote patient data review for Phase I–IV trials and non‑interventional studies to assess compliance with the protocol, ICH‑GCP, and applicable regulatory requirements. It ensures patient safety and data integrity using diverse technologies and works independently with guidance as needed.

TAF responsibilities include reviewing data listings, visualizations, and protocol deviations, communicating issues, maintaining SOPs knowledge, and

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.
• Excellent verbal and written communication to relate to internal stakeholders.
• Mastery of MS Excel (sorting, filtering, calculating, pivoting).
• Proficient with analytical data visualization tools.
• Ability to adapt and manage changing priorities.

Responsibilities

• Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.
• Reviews patient data listings and visualizations to confirm eligibility and identify deviations and safety concerns.
• Assesses factors affecting subject safety and data integrity at sites.
• Escalates serious issues and develops action plans with guidance.
• Documents observations and actions in appropriate systems for sites or team members.
• Maintains knowledge of ICH/GCP Guidelines, regulations, and SOPs.
• Verifies IP dispensing and laboratory procedures in vendor systems.
• Documents completion of activities via tracking and reporting per SOPs.
• Understands project scope, budgets, timelines; manages activities to meet objectives.
• Adapts to changing priorities with oversight, attends meetings and training as required.

Skills

Excel mastery

Analytical visualization

Verbal & written communication

Analytical skills

Computer skills

Regulatory knowledge

Education

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience

Tools

Analytical Data Visualization Tools

Job description

The Central Monitor II role at Syneos Health will perform remote patient data review for Phase I–IV trials and non‑interventional studies to assess compliance with the protocol, ICH‑GCP, and applicable regulatory requirements. It ensures patient safety and data integrity using diverse technologies and works independently with guidance as needed.

TAF responsibilities include reviewing data listings, visualizations, and protocol deviations, communicating issues, maintaining SOPs knowledge, and