Job Title: Clinical Trial Manager

Work Location: Middlesex County, Massachusetts

Summary:

The Clinical Trial Manager will oversee the operational execution of a Phase 2 open label clinical study in an adult patient population. This role is responsible for managing day-to-day trial activities, ensuring study delivery on time, within budget, and in accordance with protocol and regulatory requirements. The position requires strong leadership in clinical operations, vendor management, and cross-functional collaboration.

Responsibilities:

• Lead all operational aspects of a Phase 2 open label clinical study, including site management, vendor oversight, and coordination with contract research organizations (CROs).
• Drive site feasibility, selection, and activation processes to achieve enrollment targets and study timelines.
• Monitor CRO performance to ensure adherence to protocol, Good Clinical Practice (GCP), and regulatory standards.
• Contribute to the development and review of clinical study documents such as protocols, informed consent forms, and operational plans.
• Maintain and track study timelines, ensuring alignment with the overall clinical development plan.
• Identify potential study risks and implement mitigation strategies in collaboration with the study team and CRO partners.
• Coordinate communication and data flow among internal stakeholders, support database lock activities, and ensure Trial Master File (TMF) completeness and inspection readiness.
• Participate in process improvement initiatives and standard operating procedure (SOP) updates as needed.

Qualifications:

• Bachelor’s degree or higher in a scientific or healthcare discipline.
• 6+ years of progressive clinical trial management experience, including leadership of global pivotal trials.
• Demonstrated experience in CRO oversight and vendor management.
• Strong knowledge of ICH/GCP guidelines and clinical drug development processes.
• Experience with rare disease and/or neurology clinical trials preferred.
• Proficiency in MS Word, Excel, Outlook, PowerPoint, and MS Project.
• Excellent verbal, written, and cross-functional communication skills.
• Ability to work independently in a fast-paced environment with competing priorities.
• Must not have been out of work for more than 5 months.
• Willingness to work in a hybrid setting (2–3 days onsite per week) and travel approximately 15% as needed.

Published Category: Clinical Operations & Development