Clinical Trial Manager/Senior Clinical Trial Manager

Role Summary

The Clinical Trial Manager (CTM)/Senior CTM reports to the Vice President, Clinical Operations and is responsible for the end-to-end operational leadership and execution of Soleno’s clinical programs across all phases of development, including post-marketing, observational, and global studies. This role provides cross-functional leadership and vendor oversight to ensure trials are delivered on time, within budget, and in compliance with protocols, SOPs, ICH GCP, and applicable global regulatory requirements. The CTM partners closely with internal stakeholders and external vendors to proactively manage risk, ensure inspection readiness, and drive operational excellence in support of Soleno’s approved products and lifecycle development programs. This role requires adaptability and willingness to travel domestically and internationally as needed to support trial execution.

Responsibilities

• Study Execution & Leadership: Leads operational planning and execution of assigned clinical trials from start-up through close-out
• Study Execution & Leadership: Contributes to protocol development and review to ensure operational feasibility, site practicality, and compliance with regulatory requirements
• Study Execution & Leadership: Develops and manages timelines, budgets, and resources
• Study Execution & Leadership: Drives cross-functional alignment with Clinical Development, Regulatory, Pharmacovigilance, Data Management, QA, and CMC
• Study Execution & Leadership: Ensures inspection readiness and high-quality trial conduct across all phases
• Service Provider & CRO Oversight: Leads CRO and service provider selection and scope development
• Service Provider & CRO Oversight: Oversees service provider performance through governance, KPIs, and regular reviews
• Service Provider & CRO Oversight: Ensures appropriate sponsor oversight and compliance with contracted services
• Service Provider & CRO Oversight: Reviews and approves budgets, change orders, and invoices
• Site & Monitoring Oversight: Oversees site feasibility, selection, activation, and recruitment strategy
• Site & Monitoring Oversight: Provides oversight of monitoring activities and data quality
• Site & Monitoring Oversight: Reviews monitoring reports and addresses performance or compliance issues
• Site & Monitoring Oversight: Ensures timely resolution of protocol deviations, GCP issues, and CAPAs
• Trial Management & Compliance: Develops and reviews informed consents, feasibility assessments, study plans, manuals, and operational documents
• Trial Management & Compliance: Reviews and provides operational input on case report forms (CRFs), CRF completion guidelines, edit check specifications, and other data management documents to ensure data quality, feasibility, and alignment with protocol objectives
• Trial Management & Compliance: Participates in user acceptance testing (UAT) and validation of EDC and other clinical systems to ensure functionality supports study execution and data integrity
• Trial Management & Compliance: Ensures TMF completeness and quality
• Trial Management & Compliance: Oversees investigational product accountability
• Trial Management & Compliance: Implements risk-based quality management practices
• Trial Management & Compliance: Supports audits and regulatory inspections
• Financial & Operational Management: Manages study budgets, accruals, and forecasts
• Financial & Operational Management: Reviews and approves investigator clinical trial agreements and site payments
• Financial & Operational Management: Tracks study metrics and provides updates to leadership
• Financial & Operational Management: Identifies risks and implements mitigation strategies
• Regulatory & Clinical Reporting: Partners with Clinical Development, Biostatistics, and Medical Writing on clinical study report (CSR) planning, content review, and finalization
• Regulatory & Clinical Reporting: Provides operational input and documentation to support regulatory submissions (e.g., NDA/MAA supplements, annual reports, post-marketing commitments, safety updates)
• Regulatory & Clinical Reporting: Ensures inspection-ready documentation and timely responses to regulatory inquiries
• Regulatory & Clinical Reporting: Supports health authority inspections and audits as a clinical operations representative
• Process Improvement & Leadership: Contributes to SOP development and continuous process improvements
• Process Improvement & Leadership: Mentors and guides CTAs/CRAs and other team members
• Process Improvement & Leadership: May manage clinical operations staff and contribute to yearly evaluations, provide development opportunities and address any performance issues identified
• Process Improvement & Leadership: Supports departmental initiatives and best practices
• Process Improvement & Leadership: Performs other duties as assigned

Qualifications

• 6 – 8+ years of related clinical trial management experience
• Demonstrated experience with the unique operational and regulatory considerations of all phases, including post-marketing trials
• Rare Disease experience strongly preferred
• Experience in managing outside service providers (e.g., CROs, central laboratories, and other vendors)
• Strong knowledge of FDA, EMA, global regulatory requirements and ICH GCP
• Experience with risk-based quality management and inspection readiness
• Proven ability to manage budget and timelines
• Strong leadership, communication, and problem-solving skills to drive results that are needed to achieve company objectives
• Ability to travel domestically and internationally as required

Education

• Bachelor’s degree in life sciences or related field required