Clinical Trial Manager
New
4
4D Molecular TherapeuticsBiotechnology
Location: Remote, United StatesFull-TimeManager
Salary150,000 - 170,000 USD per year
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Job Details
- Experience
- 6+ years of clinical research experience
- Required Skills
- Microsoft Office Suite
Requirements
- B.A./B.S. degree required.
- 6+ years of clinical research experience within the Biotech or similar industry.
- Minimum 2 years of direct experience supporting clinical trial management.
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
- Experience developing trial plans, including site monitoring, risk mitigation, and clinical supply strategies.
- Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Working knowledge of MS Project for study timeline management.
- Excellent communication, organizational, and conflict resolution skills.
- Proven ability in creative problem-solving and sound judgment.
- Ability to travel up to 5% for site visits and meetings.
Responsibilities
- Manage daily operations of one or more phase 1-3 clinical trials from startup to close-out.
- Serve as the primary unmasked contact for protocol execution and oversight of CROs, study service providers, and consultants.
- Support unmasked drug supply and accountability, including oversight of IWRS systems.
- Prepare and review essential clinical trial documentation such as protocols, informed consent forms, and clinical study reports.
- Ensure Trial Master File (TMF) integrity and audit-readiness throughout trial duration.
- Conduct study-specific training for CRO staff, monitors, and investigative sites.
- Perform site visits for qualification, initiation, monitoring, and close-out as needed.
- Develop and manage study budgets to meet financial goals and review clinical invoices.
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