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 in clinical trials.
Role type
Senior Site Management Associate (Clinical Operations)
Builds
Investigator Site Files (ISF), Trial Master Files (TMF), IP-RED packages, and training programs 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, translation coordination, payment coordination, report preparation
Preferred skills
Experience in CRO environment, knowledge of project-specific systems
Technologies
MS Word, MS Excel, MS Outlook, MS PowerPoint, vendor systems, EDC systems
Responsibilities
Manage records flow with sites and off-site facilities; Coordinate payments to sites and off-site facilities; Prepare for and follow up on site audits and inspections; Review and coordinate site-specific query resolution; Arrange and track initial and ongoing trial training for investigator site teams; File trial records in the TMF and perform regular TMF checks; Prepare, distribute, and update Investigator Site Files (ISF); Collect IP-REDs and compile IP-RED packages; Serve as main vendor contact for non-trial participant issues.
