Clinical Trial Manager

Primary Responsibilities

• Oversee day-to-day trial management, coordinate cross-functional teams, and manage external vendors to ensure studies are delivered on time, within budget, and in compliance with quality and regulatory standards.
• Plan and execute mid- to late-stage clinical trials in neurology, ensuring operational excellence, data quality, and compliance with protocols, GCP, and global regulations.
• Lead daily clinical trial operations, coordinating with cross-functional teams such as Clinical Development, Data Management, Biostatistics, Regulatory, and Safety.
• Oversee CROs and external vendors, including co-monitoring activities, to ensure adherence to timelines, budgets, and quality expectations.
• Drive critical milestones such as site activation, patient enrollment, retention, data cleaning, and database lock, addressing operational challenges proactively.
• Review and approve vendor-generated plans and study documentation to ensure alignment with protocols and regulatory standards.
• Monitor study progress using operational metrics, maintaining dashboards, timelines, and financial tracking, and providing timely updates to stakeholders.
• Identify and manage operational risks, proposing mitigation strategies to minimize impact on timelines, quality, and patient safety.
• Ensure inspection and audit readiness, including oversight of Trial Master File (TMF) maintenance and close-out.
• Contribute to operational planning, regulatory deliverables, and continuous improvement of clinical operations processes.

Skills & Requirements

• Bachelor's degree in a scientific or health-related field.
• Experience managing clinical trials, preferably in neurology or CNS therapeutic development.
• Strong knowledge of ICH guidelines, GCP, and global regulatory requirements.
• 5+ years clinical trial management experience within an industry sponsor environment, supporting drug development programs.
• Proven ability to manage global clinical studies, including coordination with investigators, CROs, and vendors.
• Solid understanding of project management principles, including timeline, resource, and budget management.
• Drive critical study milestones, including site activation, enrollment progress, patient retention, data cleaning, and database lock, proactively addressing operational challenges common to CNS trials.
• Excellent communication and interpersonal skills, with the ability to influence and drive team performance.
• Proactive problem-solving mindset with the ability to anticipate issues and implement creative solutions.