Work Location: Middlesex County, Massachusetts

Summary:

The Senior Clinical Trial Manager-Phase II study will oversee the execution of a phase 2 open-label, dose-escalating clinical trial in infants and toddlers. This role involves leading cross-functional teams, managing vendor and CRO relationships, and ensuring all study deliverables are met in compliance with regulatory standards. The position is contract-to-perm, with a minimum 6-month contract before potential conversion to permanent employment. The role requires on-site presence 2–3 days per week and approximately 15% travel.

Responsibilities:

• Lead and coordinate cross-functional clinical study teams to ensure timely, on-budget, and high-quality delivery of clinical trials in accordance with protocols and regulatory guidelines.
• Oversee site feasibility, selection, and activation processes, ensuring efficient study startup and ongoing site management.
• Manage vendor and CRO qualification, selection, and oversight, including user acceptance testing and compliance with study requirements.
• Contribute to the development and review of clinical study protocols, informed consent forms, and operational plans to maintain study quality and compliance.
• Identify and mitigate study risks proactively, collaborating with internal and external stakeholders to resolve complex challenges.
• Monitor study timelines, budgets, and resource allocation, providing input on financial forecasts and accruals.
• Ensure trial master file (TMF) inspection readiness and support database lock activities through effective monitoring and data review.
• Participate in process improvement initiatives and contribute to the development of standard operating procedures (SOPs) and best practices.

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 rare disease and/or neurology clinical studies preferred.
• Proficiency in MS Word, Excel, Outlook, PowerPoint, and MS Project.
• Excellent verbal, written, and cross-functional communication skills.
• Strong analytical, problem-solving, and organizational abilities with the capacity to manage multiple priorities.
• Experience conducting or overseeing site visits (PSVs, SIVs, IMVs, COVs).
• Must not have been out of work for more than 5 months.
• Ability to work independently and collaboratively in a fast-paced environment.
• Willingness to work on-site 2–3 days per week and travel approximately 15%.

Published Category: Clinical Operations & Development