accountable for centralized monitoring activities for global and/or complex trials
analytical data review of key risk and/or operational performance data
present as an integral member of the Clinical Study team for clinical development studies
responsible for development and authoring activities of the Central Monitoring Plan
participate in the Quality Risk and Control Tracker (QRACT) development
work with data analysts in the technical configurations, implementation, and execution of Central Monitoring RBQM system across studies
document the output from Central Monitoring Review meetings and track decisions/actions

Requirements

a minimum of a Bachelor’s degree
at least 8 years of relevant experience in the biotechnology/pharmaceutical industry
minimum 3 years with direct Central Monitoring experience
proficiency and experience with CluePoint or similar RQBM system for Central Monitoring
problem solving abilities, troubleshooting and resourcefulness
analytical problem-solving experience
working knowledge of clinical drug development process, ICH, GCP guidelines, and regulations
effective communication and interpersonal skills; ability to build relationships internally and externally
demonstrates writing skills to deliver messages effectively
proficiency in Microsoft Office applications

Benefits

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Central Monitoringanalytical data reviewauthoring activitiesQuality Risk and Control Tracker (QRACT)technical configurationsimplementationexecutionproblem solvinganalytical problem-solvingclinical drug development process

Soft Skills

effective communicationinterpersonal skillsrelationship buildingwriting skillstroubleshootingresourcefulness