Associate Clinical Trial Manager – Temporary
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Job Description
Associate Clinical Trial Manager responsible for day-to-day operations of Phase 3 clinical trials at 4D Molecular Therapeutics. Requires strong communication skills and teamwork.
Responsibilities:
- 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
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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