Associate Centralized Monitoring Lead - Sponsor Dedicated (hybrid/home-based)
Ivivamedical
Fully remote
Centralized monitoring experience
Subject level data review
Ich gcp regulatory compliance
The role involves leading the execution of centralized monitoring activities across multiple sites and studies from initiation to closeout
Job Summary
The role involves leading the execution of centralized monitoring activities across multiple sites and studies from initiation to closeout.
Candidates must possess a minimum of 3 years of relevant work experience with at least 1.5 years specifically in Central Monitoring or Risk-based quality management.
The position requires ensuring subject safety, data integrity, and adherence to protocol while providing mentorship to associates and leads.
Matching Summary
The role involves leading the execution of centralized monitoring activities across multiple sites and studies from initiation to closeout.
Skills & Requirements
Must-have
Centralized Monitoring experience
Subject Level Data Review
ICH GCP regulatory compliance
Risk-based quality management
Site Visit Report review
KRI and QTL analysis
Nice-to-have
Mentorship of central monitors
Advanced analytics development
Process enhancement initiatives
Cross-cultural communication skills
Automation of ISP processes
Key Requirements
Bachelor's Degree in Clinical, Life Sciences, Math, or Nursing
Minimum 3 years of relevant work experience
Minimum 1.5 years of Central Monitoring experience
Good knowledge of ICH GCP and local regulations
Strong written and verbal English communication skills