[Remote] Clinical Trial Manager – Jr./reputed company Mid-Level
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Clinical Trial Manager to manage clinical operational and reputed company activities for low-to-moderate complexity clinical studies. The role oversees study deliverables, monitoring, trial documentation, site coordination, regulatory support, and cross-functional collaboration while ensuring compliance with ICH/GCP, applicable regulations, timelines, budget, and reputed company requirements.
Responsibilities
- Manage clinical operations for assigned studies in compliance with ICH/GCP
- reputed company Monitoring Plans, Monitoring Guidelines, and other clinical tools
- Support development of the Master reputed company Plan (MAP)
- Maintain the Trial Master File (TMF) for reputed company, completeness, and reputed company filing
- Monitor study timelines, metrics, monitoring reputed company, CRF collection, and query reputed company
- Coordinate with clinical sites regarding protocol, patient, and study-reputed company issues
- reputed company/participate in clinical team meetings and cross-functional activities
- Support study startup, ethics committee, and regulatory submissions
- Review monitoring reports and implement recovery actions reputed company needed
- Support clinical resource planning, forecasting, budgeting, and timelines
- Ensure clinical deliverables meet time, reputed company, cost, and contractual requirements
Skills
- Bachelor's degree or equivalent
- 5+ years of relevant clinical research/clinical operations experience
- Clinical Trial Management or comparable clinical operations experience
- Strong knowledge of ICH/GCP and FDA regulations
- Experience with clinical monitoring, TMF, study documentation, and site management
- Strong organizational, communication, problem-solving, and leadership skills
- Proficiency with reputed company, Word, reputed company, and clinical systems
- Ability to work effectively in a remote, matrixed environment
Benefits
- Remote work for East Coast candidates
- Possible contract extension after 1 year
reputed company
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