Clinical Trial Manager - Neurology 119425
Company: Medix™ Agency
- Location: United States
- Work mode: Remote
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Overview:
- Neurology/CNS trial experience required
- Any focused experience in data management and stats as well as the safety and CSR/medical writer management experience is highly desired
- Fully remote (US)
- Full-time
About the Job
We are seeking an experienced Clinical Trial Manager (CTM) to lead the end-to-end execution of our clinical studies. In this hands-on leadership role, you will manage study timelines, budgets, vendors, and cross-functional teams to ensure high-quality, compliant trial delivery from startup through close-out. The ideal candidate brings strong trial management expertise, sound judgment in mitigating risks, and deep familiarity with GCP and regulatory requirements.
Key Responsibilities
- Trial Execution & Compliance: Lead day-to-day study operations in compliance with protocols, SOPs, GCP, and regulations; maintain TMF completeness and inspection readiness.
- Timeline & Budget Oversight: Manage study plans, milestones, forecasts, vendor invoices, and financial reconciliations.
- Vendor & Site Management: Oversee CROs, external vendors, and clinical sites—from study startup and enrollment to monitoring, KPI tracking, and close-out.
- Systems & Data Management: Direct CTMS activities, safety database setup, and partner with Data Management on EDC development, query resolution, and database lock.
- Cross-Functional Leadership: Coordinate internal stakeholders, DMC operations, and external partners to resolve operational issues and support protocol amendments.
Qualifications
- Bachelor’s degree (B.A./B.S.) with 6+ years of relevant clinical research experience, including 1–2 years as a CTM.
- Working knowledge of GCP, trial design, scientific methodology, and pharmaceutical/medical device regulatory frameworks.
- Proven ability to manage vendors, multi-task in a fast-paced environment, and lead cross-functional teams.
- Strong communication skills and willingness to travel up to 15%.
