4D Molecular Therapeutics
Powering the Future of Genetic Medicines
Clinical Trial Manager
Location
United States
Posted
18 days ago
Salary
$150K - $178K / year
Bachelor Degree6 yrs expEnglishGoogle Cloud Platform
Job Description
• Support the Company's clinical trial activities
• Manage day to day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close out activities
• Serve as the primary contact for managing protocol execution, including oversight of the CRO, study service providers, and consultants
• Lead cross-functional study execution team
• Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs
• Assist in preparation and review of clinical trial documentation
• Ensure that the Trial Master File (TMF) is set up and maintained appropriately
• Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation
• Manage clinical trial budgets, providing ongoing financial reporting and projections
• Perform and manage data review process on an ongoing basis
• Perform site visits as needed.
Job Requirements
- B.A./B.S. degree
- 6+ years of clinical research experience within the Biotech or similar industry, with at least 2 years directly supporting clinical trial management
- Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
- Strong clinical study management skills
- Understanding of regulatory frameworks applicable to interactions with HCPs, payers, advocacy, and other business partners
- Proven clinical operational skills to direct protocol execution to ensure timeline, budget, and quality metrics are met
- Excellent communication skills to effectively disseminate information to project team and outside parties
- Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
- Working knowledge of MS Project for development and update of clinical study timelines.
Benefits
- Health insurance
- Flexible work arrangements
- Professional development opportunities
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