Clinical Trial Manager – Contract

🔥 12 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $72 - $82 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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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 Company's clinical trial activities and report to the Director of Clinical Operations • Manage day-to-day operations of one or more Phase 1–3 clinical trials, including start-up, conduct, and close-out • Serve as primary contact for protocol execution and oversee CROs, service providers, and consultants • Lead cross-functional study execution teams and track study milestones, metrics, and timelines • Ensure trials comply with ICH GCP, regulations, protocols, and company SOPs • Prepare and review clinical trial documentation, including protocols, informed consent forms, investigator brochures, monitoring plans, project plans, CRFs, SAPs, and clinical study reports • Establish and maintain the Trial Master File and support audit readiness and resolution of audit findings • Participate in service-provider selection and support issue resolution and process improvement • Assess operational feasibility, recommend study execution plans and site selection, and train CRO staff, monitors, sites, and service providers • Facilitate clinical trial agreements with the legal group • Manage clinical trial budgets, financial reporting, projections, site contracts, and invoices • Perform ongoing data review and site visits, including qualification, initiation, monitoring, and close-out • Oversee outsourced monitoring, protocol deviation tracking, clinical supplies forecasting, and site issue resolution • May manage junior Clinical Operations staff and support Clinical SOP development • Travel to sites, conferences, and industry meetings as needed

🎯 Requirements

• B.A./B.S. degree in Science • 6+ years of clinical research experience within the Biotech or similar industry • At least 2 years directly supporting a retina clinical trial • Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management • Understanding of regulatory framework applicable to interactions with HCPs, payers, advocacy, and other business partners • Proven clinical operational skills to direct protocol execution and meet timeline, budget, and quality metrics • Experience reviewing trial plans, including site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management • Clinical research knowledge and cross-functional understanding of clinical trial methodology • Proficient Microsoft Office Suite skills, including Word, Excel, PowerPoint, and Outlook • Working knowledge of MS Project for clinical study timelines • Ability to travel as needed; stated travel expectation is 5% • Global APAC experience desired

🏖️ Benefits

• Equal employment opportunities without regard to protected characteristics • Travel as needed to sites, conferences, and industry meetings • Potential professional development through internal training and external conference attendance