Job Title: Senior Clinical Trial Manager

Work Location: Middlesex County, Massachusetts

Summary:

The Senior Clinical Trial Manager is responsible for leading and managing all aspects of global clinical trials, ensuring studies are executed efficiently, on time, and in compliance with regulatory standards. This role involves oversight of cross-functional teams, vendors, and CROs, with a focus on rare disease and neurology programs. The position requires strong leadership, risk management, and process improvement skills, as well as the ability to work in a hybrid setting with regular onsite presence.

Responsibilities:

• Direct cross-functional clinical study teams and oversee all phases of assigned clinical trials, ensuring adherence to protocols, timelines, and regulatory requirements.
• Manage site feasibility, selection, and activation processes, including country identification and timely site start-up activities.
• Supervise vendor and CRO qualification, selection, and ongoing oversight to ensure quality and compliance with study protocols and GCP standards.
• Contribute to the development and review of clinical study protocols, informed consent forms, and operational plans to maintain study quality and compliance.
• Identify potential study risks proactively and implement effective risk mitigation strategies in collaboration with internal and external stakeholders.
• Oversee clinical study budgeting, provide financial input for accruals and forecasts, and participate in scenario planning for timelines and costs.
• Ensure Trial Master File (TMF) inspection readiness and support database lock activities through effective monitoring and data review processes.
• Drive process improvement initiatives and contribute to the development of standard operating procedures (SOPs) and best practices within clinical operations.

Qualifications:

• Bachelor's degree or higher in a scientific or healthcare discipline.
• 8+ years of progressive experience in clinical trial management, including leadership of global pivotal trials.
• Demonstrated experience with CRO oversight and vendor management.
• Strong knowledge of ICH-GCP guidelines and the clinical drug development process.
• Experience with site visits (PSVs, SIVs, IMVs, COVs) and clinical study documentation.
• Rare disease and/or neurology clinical trial experience preferred.
• Proficiency in MS Word, Excel, Outlook, PowerPoint, and MS Project.
• Excellent communication, analytical, organizational, and problem-solving skills.
• Ability to manage multiple priorities independently and collaboratively in a fast-paced environment.
• Willingness to travel approximately 15% as required.

Published Category: Clinical Operations & Development