Senior Clinical Trial Manager – Contract

🔥 10 minutes ago

🇺🇸 United States – Remote

💵 $84 - $98 / hour

⏳ Contract/Temporary

🟠 Senior

🧪 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

• Oversee and manage day-to-day operations of multiple Phase 1–3 clinical trials, including trial start-up, conduct, and close-out • Manage protocol execution and oversee CROs, study service providers, and consultants • Establish study milestones and track and report study metrics and timelines to leadership • Ensure trials comply with ICH GCP, regulations, protocols, and company SOPs • Prepare and review protocols, informed consent forms, pharmacy and laboratory manuals, monitoring plans, project plans, CRFs, vendor management plans, clinical study reports, and other study documents • Develop internal tracking and reporting tools and facilitate internal project team meetings • Support Trial Master File management and inspection readiness • Coordinate resolution of audit findings and maintain audit-ready clinical trial documentation • Identify, mitigate, and manage risks, including issue review, escalation, trend analysis, and prevention • Support selection and study-specific training of CRO staff, monitors, investigational sites, and service providers • Facilitate study start-up with CROs and clinical sites, including source document worksheets, CRF specifications, clinical site agreements, and other documentation • Assist with database lock, clinical study data analyses, and clinical study reports • Ensure timely responses to queries and monitoring discrepancies • Aid in planning and execution of investigator meetings • Participate in cross-functional study execution team meetings • Conduct or coordinate clinical site, CRO, and vendor monitoring and co-monitoring visits • Oversee outsourced monitoring and resolve site-related issues • Track and review protocol deviations and assess impact on study data • Oversee clinical supply forecasting for study drug and other supplies • May manage or oversee junior Clinical Operations staff • May support Clinical SOP development and department initiatives • Travel as needed to sites, conferences, and industry meetings

🎯 Requirements

• B.A./B.S. degree • 7+ years of clinical research experience within the biotech or a similar industry • Experience developing trial plans, including creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management • Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management • Understanding of, and experience with, the regulatory framework applicable to interactions with HCPs, payers, advocacy groups, and other business partners • Proven leadership skills to direct protocol execution and ensure timeline, budget, and quality metrics are met • Excellent communication skills • Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology • Excellent organizational, conflict resolution, prioritization, and negotiation skills • Proven ability in creative problem-solving and exercising sound judgment • Ability to collaborate effectively with study teams, cross-functional team members, and external partners • Ability to handle a high volume of highly complex tasks within a given timeline • Proficient computer skills, specifically Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook • Working knowledge of MS Project for developing and updating clinical study timelines • Ability to travel as needed to sites, conferences, and industry meetings • Sedentary work and repetitive wrist, hand, and finger motions; frequent speaking • Must follow applicable company, protocol, regulatory, and ICH GCP requirements

🏖️ Benefits

• Career development opportunities • Internal training and external conference attendance • Equal employment opportunities • 20% travel

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