Associate Clinical Trial Manager

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $117k - $132k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

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4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏭 Manufacturing

🧬 Biotechnology

Consulting • Manufacturing • Biotechnology

4D Molecular Therapeutics is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine, aiming to treat both large market and rare diseases. Utilizing its Therapeutic Vector Evolution platform, the company leverages directed evolution to create customized AAV vectors with superior therapeutic profiles. With a diverse pipeline including five product candidates in clinical trials targeting seven patient populations, 4DMT is committed to addressing challenges in genetic medicine and pursuing potential curative therapies while fostering a collaborative and innovative environment.

📋 Description

• Support the day-to-day operations of one or more Phase 1–3 clinical trials across start-up, conduct, and close-out activities • Coordinate tracking of clinical trials under Clinical Trial Management oversight • Collect, track, and conduct initial completeness reviews of site regulatory documents for IP release and TMF filing • Organize, maintain, and participate in audits and close-out of the TMF/eTMF • Maintain tracking spreadsheets for subject, essential document, sample, and investigational product progress • Track and coordinate CRO and third-party vendor activities, including meeting minutes, study updates, and trackers • Review site regulatory documents for accuracy and compliance with SOPs and regulatory guidelines • Provide timely updates for ClinicalTrials.gov site updates and changes • Route CDAs, contracts, and work orders through the legal approval process • Review site and vendor invoices and generate monthly/quarterly accruals for finance • Assist with site tools, clinical trial start-up, study materials, pharmacy manuals, vendor setup, and specifications • Communicate with sites, CROs, and CRA/monitors to support start-up, study conduct, and close-out • Track trial progress, monitoring visit reports, unresolved issues, clinical lab samples, shipments, and central reader/lab data • Use EDC/CTMS systems to acquire and synthesize clinical trial data, metrics, and reports • Assist with internal, investigator, and trial-specific meetings, including minutes and action-item tracking • Travel as business needs demand and perform other assigned duties

🎯 Requirements

• B.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 applicable regulatory requirements • Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, SharePoint, and Outlook • Ability to prioritize and manage competing priorities • Ability to collaborate effectively with study teams, cross-functional team members, and external partners • Willingness to travel; the posting states 30% travel • Ability to perform sedentary work involving sitting most of the time and occasional walking/standing