Senior Clinical Trial Manager

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $180k - $195k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Jade Biosciences

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jade Biosciences is a clinical-stage biotechnology company developing potentially best-in-class therapies aimed at transforming the standard of care for autoimmune diseases. Its lead candidate, JADE101, is an antibody designed to inhibit the cytokine APRIL (A PRoliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN). The company builds its pipeline from discovery-stage assets licensed from Paragon Therapeutics and is focused on advancing clinical programs to deliver new treatments for patients with autoimmune conditions.

📋 Description

• Support the Director, Clinical Operations, in planning and operational execution of assigned clinical trials • Coordinate day-to-day study activities across cross-functional partners, clinical sites, CROs, and vendors • Maintain study plans, timelines, budgets, risks, and key documentation • Oversee vendor deliverables, performance metrics, issue resolution, meeting governance, invoices, and scope tracking • Maintain clinical trial budgets and forecasts; review invoices, track spend, identify variances, and escalate financial risks • Maintain risk, issue, decision, and action logs; drive mitigation and resolution activities • Coordinate operational input into protocols, monitoring plans, informed consent forms, investigator brochures, manuals, and clinical study reports • Oversee study start-up, site activation, enrollment, conduct, monitoring, closeout, and inspection-readiness activities • Support investigator meetings and monitoring oversight • Build relationships with clinical sites, investigators, CROs, vendors, and internal stakeholders • Review study performance metrics and implement corrective and preventive actions • Ensure trial activities and documentation comply with protocols, Good Clinical Practice, regulations, contracts, and company procedures • Coordinate operational requirements and timelines across clinical supply, laboratories, data management, safety, biostatistics, medical monitoring, and regulatory activities • Maintain an accurate, inspection-ready Trial Master File and support audits, inspections, and quality oversight • Mentor Clinical Trial Associates and Clinical Trial Managers, contribute to process improvements, and prepare study updates for governance and senior leadership

🎯 Requirements

• Bachelor’s degree and 10+ years of related experience for Senior Clinical Trial Manager, or 7+ years of related experience for Clinical Trial Manager • Trial management experience within a biopharmaceutical company • Ability to manage complex clinical trial activities, timelines, vendors, budgets, risks, and cross-functional deliverables with appropriate independence and escalation • Experience supporting Phase 1 through Phase 3 clinical trials • Experience managing CROs and clinical vendors, including laboratories, RTSM, EDC, and ancillary clinical technology or applications • Strong working knowledge of FDA regulations, ICH guidelines, Good Clinical Practice, medical terminology, and clinical trial conduct • Working knowledge of clinical protocol implementation, regulatory submissions, Trial Master File requirements, and the overall drug development process • Excellent communication, organization, collaboration, problem-solving, and attention-to-detail skills, with the ability to manage competing priorities • Authorization to work in the United States verified through Form I-9 and E-Verify

🏖️ Benefits

• Remote work • Periodic travel to team and company events • Equal Opportunity employment