Senior Site Management Associate
Core
Main site contact for non-trial-participant issues, managing records flow, regulatory submissions, payments, audits, and training for investigator site teams.
Role type
Senior Site Management Associate (Clinical Operations)
Builds
Investigator Site Files (ISF), Trial Master Files (TMF), regulatory submission packages, and training materials for sites.
Domain
Clinical Research / Pharmaceutical Trials
Deliverable
client delivery
Required skills
Vendor management, regulatory document preparation, audit coordination, site query resolution, EDC progress tracking, training coordination, TMF management, ISF management, translation coordination, IP-RED compilation
Preferred skills
Experience in CRO environment, knowledge of vendor systems
Technologies
MS Word, MS Excel, MS Outlook, MS PowerPoint, vendor-specific trial systems
Responsibilities
Manage records flow with sites and off-site facilities; coordinate payments to sites and facilities; prepare for and follow up on site audits and inspections; review and coordinate site-specific query resolution; review EDC completion progress; organize Investigator Meetings; provide on-the-job coaching to junior staff; arrange and track trial training for investigator teams; file trial records in TMF and perform TMF checks; prepare and update Investigator Site Files (ISF); coordinate translation of trial records; collect and compile IP-RED packages.
Seniority
Senior, hands-on IC with coaching responsibilities