Responsibilities:

• Review protocol, critical data, and process, safety, and data integrity risks related to protocol execution
• Review patient data listings and visualizations via analytical dashboards and/or reports
• Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site
• Communicate/escalate serious issues to the project team and develop action plans
• Document observations and write queries, protocol deviations, or action items as necessary
• Maintain a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes

Requirements:

• 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
• Good computer skills and ability to embrace new technologies
• Mastery of MS Excel and Analytical Data Visualization Tools
• Excellent verbal and written communication skills
• Strong analytical skills
• Developing therapeutic expertise

Benefits:

• Career development and progression opportunities
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Total Self culture allowing authentic self-expression

Job Data by YubHub.