Note: The job is a remote job and is open to candidates in USA. Catalyst Pharmaceuticals, Inc. is a pharmaceutical company focused on clinical development and rare disease therapies. The Clinical Trial Manager provides end-to-end operational leadership for assigned clinical programs, coordinating cross-functional teams, vendors, timelines, budgets, risks, and regulatory compliance across the study lifecycle. The role also drives inspection readiness, stakeholder governance, and continuous improvement in clinical trial execution.
Responsibilities
- Program & Study Execution Leadership: Leads development and execution of integrated clinical program and study-level plans in partnership with cross-functional stakeholders, ensuring alignment with overall development strategy, regulatory requirements, and corporate objectives
- CRO & Vendor Oversight: Provides strategic oversight and performance management of CROs, vendors, and external partners, including governance, KPI tracking, and issue escalation to ensure high-quality, cost-effective delivery
- Cross-Functional Integration & Planning: Collaborates with Clinical Operations, Clinical Development, Regulatory, Biostatistics, Data Management, and other functional areas to develop and maintain realistic timelines, budgets, and resource plans; identifies and proactively manages critical path activities and dependencies
- Risk-Based Study Management: Implements and drives risk-based trial management approaches, including proactive risk identification, mitigation planning, and continuous monitoring of key study risks and operational signals
- Performance & Delivery Management: Monitors study progress against milestones, deliverables, and KPIs using data-driven insights; proactively identifies variances and leads corrective and preventive actions to ensure on-time, within-scope, and on-budget delivery
- Stakeholder Communication & Governance: Ensures transparent, timely, and effective communication of program status, risks, decisions, and milestones to internal and external stakeholders through structured governance, reporting, and escalation pathways
- Cross-Functional Leadership & Influence: Demonstrates the ability to appropriately challenge, influence, and motivate cross-functional team members and partners to drive accountability, decision-making, and high-performance execution across multiple concurrent studies
- Quality & Inspection Readiness: Ensures clinical studies are continuously inspection-ready, with adherence to GCP, SOPs, and regulatory requirements; leads preparation for audits/inspections and ensures timely resolution of findings through effective CAPA management
- Operational Excellence & Continuous Improvement: Identifies opportunities to enhance processes, tools, and ways of working; contributes to the implementation of innovative solutions (i.e. digital tools, decentralized trial elements, AI analytics) to improve study execution
- Additional Responsibilities: Performs other duties as assigned, consistent with the evolving needs of the clinical development organization
Skills
- • Bachelor's degree in science/health-related field
- • 5 to 7 years of clinical research experience with at least 5 years of clinical trial management experience
- • Therapeutic experience in the areas of Neurology, or Rare/Orphan Disease required
- • A thorough and working understanding of FDA and GCP/ICH guidelines
- • Excellent written and oral communication skills with the ability to manage multiple priorities
- • Ability to travel 25% to clinical trial sites and/or CROs
- Master's degree is preferred
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Generous paid time off
- A retirement savings plan with Company Match
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