Senior Clinical Trial Manager

Benefits

Qualifications

• •Bachelor’s degree (science or related)
• •eTMF experience (filing, QC, and inspection readiness mindset)
• •Sharp organization, high attention to detail, and comfort juggling priorities
• •Strong communication skills with study teams, sites, and vendors
• •Microsoft Office proficiency
• •Travel up to ~20%
• •3 more items(s)

Responsibilities

• •CTA to support late-phase clinical study execution in a smaller-company environment
• •Own study document collection/tracking (CVs, 1572s, IRB approvals, lab certs, contracts, protocols, etc.)
• •Set up/maintain/close out TMF/eTMF; run QC and fix discrepancies
• •Maintain core study trackers/metrics (contacts, vendor lists, visit reports, monitoring visit tracking, samples, supplies)
• •Build agendas and capture clean, actionable meeting minutes (internal + external)
• •Support investigator meetings, monitor workshops, and study manuals
• •Coordinate document workflows with Regulatory Affairs to hit submission timelines
• •Support data reconciliation and help with database/listing review as assigned
• •Maintain clinical trial public postings (e.g., ClinicalTrials.gov, EU registries)
• •Support clinical trial insurance documentation and renewals
• •7 more items(s)