Clinical Trial Manager
Company: Planet Pharma Agency
- Location: South San Francisco, United States
- Employment type: Contract
- Posted: Yesterday
- Offer language: English
Job description
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 within 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.
