Details:
- Compensation: $75 - $90/hour
- Benefits: Medical, Dental, Vision
- Employment Classification: FSP
- Status: Remote
- Job ID: 22137
Clinical Trial Manager (CTM) Job Description
Job Title: Clinical Trial Manager (CTM)
Work Location: Santa Clara County, California
Summary:
Seeking an experienced Clinical Trial Manager to oversee the execution and operational aspects of clinical trials, ensuring compliance, quality, and timely progress across multiple sites and vendors.
Responsibilities:
- Direct daily clinical trial activities, including site management, monitoring oversight, and enrollment tracking.
- Lead and mentor the clinical research associate team, reviewing monitoring visit reports and ensuring timely resolution of follow-up actions.
- Maintain oversight and completeness of the trial master file, tracking study timelines and metrics.
- Coordinate with functional vendors such as central labs, IRT, ePRO/eCOA, and central raters to resolve operational challenges.
- Facilitate the transition from study start-up to site activation, driving progress toward first patient-in milestones.
- Ensure continuous inspection readiness across all sites and maintain up-to-date documentation.
- Collaborate with cross-functional teams to support trial execution and address operational issues as they arise.
- Monitor and report on study progress, proactively identifying risks and implementing mitigation strategies.
Qualifications:
- Minimum 4 years of experience in clinical trial management or as a senior clinical research associate, including leadership of teams or workstreams.
- Comprehensive knowledge of ICH-GCP guidelines and hands-on experience with CTMS, eTMF, and monitoring oversight.
- Strong coordination and communication skills for effective collaboration with sites, CRAs, and vendors.
- Bachelor’s degree in a life science or related field required; advanced degree preferred.
- Experience with CNS or psychiatry clinical trials, including short-duration and open-label study designs, is highly desirable.
- Demonstrated ability to oversee sites in the UK/EU in addition to US-based sites is a plus.
Published Category: Clinical Operations & Development



