Clinical Trial Manager (Hybrid)

Role Summary

The Clinical Trial Manager (CTM) will plan, execute, and oversee global clinical trials, ensuring high-quality delivery in alignment with ICH-GCP, regulatory requirements, and corporate objectives. This role provides day-to-day operational leadership, manages CROs and vendors, and contributes to the development of processes that support the growth of the Clinical Operations function. Location: Cambridge, MA; hybrid role with a minimum 50% on-site presence.

Responsibilities

• Manage daily clinical trial operations across all trial phases (startup through closeout), ensuring adherence to timelines, budget, and quality standards.
• Lead planning, implementation, and execution of global clinical trials, coordinating cross-functional team activities and CRO resources.
• Oversee CROs and vendors, monitor performance metrics, and ensure timely and high-quality deliverables.
• Develop and contribute to patient recruitment plans, enrollment projections, and supporting documentation.
• Lead study-specific meetings, including internal team meetings, CRO/vendor meetings, and Investigator Meetings.
• Provide input on key study documents including protocols, ICFs, eCRFs, monitoring conventions, and edit checks.
• Deliver study-specific training to CRO staff and internal team members as needed.
• Track study timelines, enrollment, protocol deviations, data trends, and sample management in partnership with Data Management and Clinical Development.
• Support risk identification, mitigation planning, and contribute to Risk-Based Quality Management and Operational Excellence initiatives.
• Maintain inspection readiness and ensure compliance with SOPs and regulatory standards.
• Assist in the development and management of study budgets; review and approve clinical vendor invoices.
• Prepare regular study updates, presentations, and risk assessments for senior leadership.
• Mentor and provide oversight for junior Clinical Operations staff, including CTAs and Sr. CTAs.
• Contribute to process improvement initiatives, development of SOPs, and operational best practices for the Clinical Operations department.

Qualifications

• Bachelor’s degree in a scientific or health-related field required; Master’s or PhD preferred. Equivalent work experience considered.
• 5 years related experience with a Bachelor’s degree, 3 years with a Master’s degree, or PhD with no experience; or equivalent experience.
• Minimum 2 years managing clinical trials.
• Experience managing global clinical trials across Phase I–III strongly preferred.
• Strong knowledge of ICH-GCP and global regulatory requirements.
• Experience in biotech/pharma environment required.
• Ability to manage multiple tasks in a fast-paced, matrixed environment.