Clinical Trial Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $130k - $147k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Catalyst Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2002

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Catalyst Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies for people with rare and debilitating diseases such as Lambert-Eaton myasthenic syndrome (LEMS), epilepsy, and Duchenne muscular dystrophy (DMD). Catalyst is dedicated to advancing cutting-edge science and improving the lives of patients through its clinical research pipeline, approved products, and compassionate use programs. The company actively engages in environmental, social, and governance (ESG) responsibilities and strives for social responsibility in all its endeavors.

📋 Description

• Provide end-to-end leadership and operational oversight for assigned clinical programs • Lead execution of Clinical Trial Team activities across the study lifecycle • Drive integrated delivery of clinical trials in alignment with corporate strategy and regulatory, GCP, and quality standards • Orchestrate cross-functional teams while managing timelines, budgets, resources, and risks • Lead development and execution of integrated clinical program and study-level plans • Oversee CROs, vendors, and external partners, including governance, KPI tracking, and issue escalation • Collaborate with Clinical Operations, Clinical Development, Regulatory, Biostatistics, Data Management, and other functional areas • Implement risk-based trial management, including risk identification, mitigation planning, and monitoring • Monitor study progress against milestones, deliverables, and KPIs; lead corrective and preventive actions • Communicate program status, risks, decisions, and milestones to stakeholders • Influence cross-functional team members and partners across multiple concurrent studies • Ensure studies remain inspection-ready and adhere to GCP, SOPs, and regulatory requirements • Lead audit and inspection preparation and resolution of findings through CAPA management • Identify and implement process, tool, and workflow improvements, including digital tools, decentralized trial elements, and AI analytics • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree in science/health-related field required; Master’s degree preferred • 5 to 7 years of clinical research experience • At least 5 years of clinical trial management experience • Therapeutic experience in Neurology or Rare/Orphan Disease required • Thorough and working understanding of FDA and GCP/ICH guidelines • Excellent written and oral communication skills • Ability to manage multiple priorities • Ability to travel 25% to clinical trial sites and/or CROs • Successful completion of required screening and verification processes • Authority to work in the United States

🏖️ Benefits

• Health, dental, and vision insurance • Generous paid time off • Retirement savings plan with Company Match • Competitive wages