Clinical Trial Manager

Position Overview

We are seeking an experienced Clinical Trial Manager (CTM) to lead the day-to-day operational planning, execution, and oversight of global clinical trials. The CTM will be accountable for driving assigned studies from start-up through close-out, ensuring that trials are conducted on time, within budget, and in accordance with study protocols, ICH-GCP, applicable regulatory requirements, and company standards.

This is a hands-on role well suited to an experienced clinical operations professional who thrives in a fast-paced biotechnology environment. The CTM will work closely with CROs, investigative sites, external vendors, and cross-functional colleagues in Clinical Development, Data Management, Regulatory Affairs, Biometrics, Safety, and other functions to ensure high-quality study execution.

Key Responsibilities

• Lead the operational execution of assigned clinical trials from study start-up through close-out, including site selection and activation, enrollment, study conduct, monitoring, and trial close-out.
• Develop, maintain, and drive study timelines, budgets, enrollment plans, and operational deliverables, proactively identifying risks and implementing mitigation plans.
• Provide day-to-day oversight of CROs, clinical sites, and other study vendors to ensure adherence to contractual obligations, timelines, quality standards, and study requirements.
• Coordinate and contribute to the development and review of clinical trial documents, including protocols, informed consent forms, study plans, site materials, monitoring plans, and clinical study reports.
• Track study progress and key performance indicators, including site activation, enrollment, monitoring, data quality, protocol deviations, and vendor performance, escalating significant risks as appropriate.
• Partner with Clinical Development, Data Management, Biostatistics, Regulatory Affairs, and other functions to resolve operational issues and support timely study execution.
• Lead or participate in study team meetings, vendor meetings, investigator meetings, and other trial-related activities.
• Support the identification and implementation of appropriate monitoring strategies, including risk-based monitoring approaches, to protect participant safety and maintain data quality and integrity.
• Oversee clinical trial documentation and support the completeness and inspection readiness of the Trial Master File (TMF).
• Manage operational challenges associated with CNS clinical trials, including patient recruitment and retention, biomarker and sample collection, site capabilities, and protocol complexity, as applicable.
• Support clinical development programs as they transition from preclinical development into first-in-human and subsequent clinical studies.
• Ensure assigned studies are conducted in compliance with applicable requirements, including ICH-GCP and relevant FDA, EMA, and NMPA regulations and guidance.
• Support regulatory submissions, health authority interactions, audits, and inspections by ensuring appropriate clinical operations documentation and study readiness.
• Identify and implement process improvements that enhance study quality, efficiency, and execution.
• Perform other clinical operations responsibilities as needed to support the development portfolio.

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or a related discipline required; advanced degree preferred.
• A minimum of 4 years of clinical operations experience within the biotechnology, pharmaceutical, or CRO industry, with at least 2 years as a sponsor, with demonstrated responsibility for managing clinical trials or major study activities.
• Hands-on experience managing Phase I-III clinical trials, including CRO, vendor, and investigative-site oversight; global clinical trial experience strongly preferred.
• Experience with CNS or neurology clinical trials preferred.
• Strong working knowledge of ICH-GCP and applicable FDA and other global regulatory requirements governing clinical research.
• Demonstrated experience managing study timelines, budgets, vendors, enrollment, and operational risks.
• Experience with clinical trial systems and processes, including CTMS, eTMF, EDC, and study monitoring.
• Strong organizational skills and attention to detail, with demonstrated ability to identify and resolve issues that may affect study timelines, quality, or data integrity.
• Ability to proactively manage challenges such as site activation delays, enrollment issues, protocol deviations, vendor performance, and competing study priorities.
• Strong interpersonal and communication skills, with the ability to build productive relationships with investigative sites, CROs, vendors, and internal stakeholders.
• Ability to work effectively across functions and geographies in a highly collaborative environment.
• Ability to operate independently, manage multiple priorities, and adapt to changing program needs in a dynamic, development-stage biotechnology company.
• Willingness to travel domestically and internationally as required for study activities (estimated as <10%).

About Sironax

Sironax is a global clinical-stage biotechnology company focused on developing innovative therapies for neurodegenerative, inflammatory, immunologic, and rare diseases. Driven by scientific excellence and a patient-centered mission, Sironax is expanding its global presence to transform treatment paradigms and improve outcomes for patients worldwide.

Equal Opportunity Employer

Sironax is an equal opportunity employer committed to diversity, equity, and inclusion. We welcome applicants from all backgrounds and are dedicated to creating a work environment where everyone feels valued and empowered.