Clinical Trial Manager

The Clinical Trial Manager (CTM) provides end-to-end leadership and operational oversight for assigned clinical programs, driving execution of Clinical Trial Team activities across the study lifecycle. In close partnership with the Sr. Director, Clinical Development and Clinical Operations Leadership, the CTM is accountable for the integrated delivery of clinical trials ensuring alignment with corporate strategy and full compliance with regulatory, GCP, and quality standards. The CTM serves as the central orchestrator of cross-functional teams, proactively managing timelines, budgets, resources, and risks to deliver studies on time, within scope, and on budget. This role emphasizes data-driven decision-making, vendor and stakeholder management, and continuous process optimization to enable high-quality, inspection-ready clinical execution. Responsibilities (include but not limited to) 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 Education/Experience/Skills Bachelor’s degree in science/health-related field; Master’s degree is preferred. 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 Catalyst is committed to providing competitive wages and comprehensive benefits including health, dental, and vision insurance, generous paid time off, a retirement savings plan with Company Match, and more. Further details about our benefits package can be found here: The base salary for this position will range from $130,000 to $147,000. Candidate experience, professional licensing, and geographic location will be taken into consideration. Employment is contingent upon successful completion of all required screening and verification processes, including for authority to work in the United States. EEO Statement Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status. Recruitment & Staffing Agencies: Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources. #J-18808-Ljbffr BioSpace