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Powering the Future of Genetic Medicines
Associate Clinical Trial Manager – Temporary
Location
United States
Posted
66 days ago
Salary
$62K - $72K / hour
Seniority
Mid Level
Job Description
Associate Clinical Trial Manager – Temporary
4D Molecular Therapeutics
• Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Management • Collect, track and conduct initial review for completeness of site regulatory documents and/or TMF filing • Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF) • Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking • Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers • Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance • Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations • Communicate directly with sites handling triages, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with study conduct, and/or close-out activities • Assist with tracking of clinical trial progress including status update reports, as requested • Assist with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking • Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM, specific meetings or management updates • May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues • Other duties as may be assigned
Job Requirements
- A./B.S. degree required
- At least 5 years of work experience supporting clinical trials
- Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements
- Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, SharePoint and Outlook
- Ability to prioritize and manage competing priorities
- Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners.
Benefits
- Equal employment opportunities without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
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