Clinical Trial Manager

Contract Clinical Trial Manager (6-12 months) REMOTE

Job Summary

The Clinical Trial Manager (CTM) will support the day-to-day execution and oversight of clinical trials in collaboration with Clinical Operations team members, cross-functional partners, CROs, and external vendors. This role will provide hands‑on operational support across key study activities, including monitoring visit report review, protocol deviation review, Trial Master File (TMF) oversight, subject tracking, central laboratory coordination, and other study-related activities.

The CTM will help ensure studies are executed in accordance with study plans, timelines, applicable procedures, and regulatory requirements while proactively identifying and escalating operational issues.

Job Responsibilities

• Support day-to-day clinical trial execution in partnership with Clinical Operations study leads and cross-functional teams.
• Review monitoring visit reports (MVRs) for quality, completeness, appropriate follow-up, and site-level issues requiring escalation.
• Review and track protocol deviations, including documentation, follow‑up, and identification of trends.
• Support TMF oversight and inspection readiness, identifying documentation or quality gaps and driving follow‑up through resolution.
• Support subject tracking across screening, enrollment, treatment, and key study milestones, including critical assessments and procedures.
• Support central laboratory activities, including tracking sample‑related and operational issues and coordinating follow‑up with sites, CROs, and vendors.
• Support central imaging and procedure vendor activities, including coordination and tracking of DXA, biopsy, and EGD activities and related operational issues.
• Review study data listings and operational reports to identify trends, discrepancies, and follow‑up items.
• Partner with CROs and vendors to track site activities, deliverables, operational risks, and issues through resolution.
• Support study documentation, trackers, meetings, cross‑functional coordination, and other Clinical Operations activities needed for effective trial execution.

Qualifications

• At least 4+ years of relevant experience with either a BS/BA in a relevant scientific discipline or an RN qualification (2- or 3-year program)

Technical Requirements and Skills

• Experience with in the pharmaceutical, biotechnology, CRO, or healthcare industry.
• Working knowledge of ICH‑GCP and applicable clinical trial regulations.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities.
• Strong written, verbal, and interpersonal communication skills.
• Ability to collaborate effectively with cross‑functional teams, CROs, sites, and external vendors.
• Proficiency with Microsoft Word, Excel, and PowerPoint, with familiarity with clinical trial systems and tools.