About this role
Job title: Clinical Adjudication Lead
About the Role This role supports clinical research studies across all phases with a focus on adjudication and endpoint review to ensure data quality, safety and protocol compliance. The incumbent will become a Subject Matter Expert on the adjudication process and collaborate with study teams, vendors, CROs, biostats and safety physicians to drive timely, accurate decisions.
What You'll Do
- Adjudication / Endpoint Workstream Planning and Execution: maintain program productivity, describe interactions with adjudication vendor, and act as an extended team member across multiple studies.
- Provide clinical administrative support to Adjudication Committee, prepare agendas, collect documents, and oversee payments requests for AC members if applicable.
- Oversee Adjudication Documentation: Charters, Plans, Site Manuals, Quick Reference guides; coordinate translations; reconcile TMF by compound and protocol; identify and resolve reconciliation issues.
- Analyze ILD adjudication metrics, monitor site performance, identify trends, missing eDC pages, image upload issues; propose solutions to Study Team / CRO.
- Track site start-up, recruitment, expansion to new countries, replacement sites; monitor milestones and timelines.
- Participate in ILD Adjudication training at Investigator Meetings, Site Initiations, and global CRA trainings; optimize communications with sites and coordinators; analyze reports from electronic adjudication system for discrepancies.
What We're Looking For
- Education: Master's degree with 3+ years of relevant experience or Bachelor's degree with 5+ years relevant experience.
- Experience/Knowledge: Knowledge of ICH/GCP and regulatory guidelines preferred; Knowledge of adjudication processes and working with adjudication committees and/or Independent Review Committees preferred.
- Skills: Strong organizational skills; attention to detail; ability to manage multiple studies; effective cross-functional communication.
- Travel: Ability to travel up to 10% of the time; global travel as needed.