Clinical Trial Manager
New
4
4D Molecular TherapeuticsBiotechnology
Remote, United StatesFull-TimeManager
Salary150,000 - 172,000 USD per year
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Job Details
- Experience
- 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management
- Required Skills
- Microsoft Office SuiteBudget management
Requirements
- B.A./B.S. degree
- 6+ years of clinical research experience in Biotech or similar industry
- At least 2 years directly supporting clinical trial management
- Knowledge of GCP, ICH guidelines, and regulatory requirements
- Strong clinical study management and operational skills
- Experience in site monitoring, risk mitigation, and trial budget development
- Proven experience with cross-functional team collaboration
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
- Working knowledge of MS Project
Responsibilities
- Serve as the primary contact for managing protocol execution and overseeing CROs and study service providers
- Lead cross-functional study execution teams
- Ensure trial compliance with ICH GCP, regulations, and company SOPs
- Manage Trial Master File (TMF) setup, maintenance, and periodic reviews
- Prepare and review clinical trial documentation
- Manage clinical trial budgets, financial reporting, and forecasting
- Negotiate and finalize site contracts and budgets
- Perform and manage ongoing data review processes
- Conduct site visits including qualification, initiation, monitoring, and close-out
- Oversee forecasting of clinical supplies and study drugs
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