Clinical Trial Manager – Contract
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Job Description
Clinical Trial Manager managing clinical trial activities at 4D Molecular Therapeutics. Overseeing daily operations of phase 1-3 clinical trials as a remote position.
Responsibilities:
- Serve as the primary contact for managing protocol execution, including oversight of the CRO, other study service providers, and consultants that are involved in a clinical trial
- Lead cross-functional study execution team in support of study deliverables
- Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership
- 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 such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents
- Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews
- Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation including central clinical files
- Negotiate and finalize site contracts and budgets
- Manage clinical trial budgets, providing ongoing financial reporting and projections
- Perform and manage data review process on an ongoing basis
- Perform site visits including site qualification, initiation, monitoring and close-out visits, as needed
- Oversee outsourced monitoring by reviewing, monitoring reports to ensure quality and resolution of site-related issues.
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, and experience with, regulatory framework 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 organizational, conflict resolution, prioritization and negotiation skills
- Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
- 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
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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