Senior Clinical Trial Manager (CTM)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Trial Manager (CTM) based in the United States. The Senior Clinical Trial Manager will lead the planning, execution, and closeout of domestic and international clinical trials, ensuring studies meet rigorous quality, regulatory, and operational standards. This role spans the full clinical development lifecycle, from study design and feasibility through data analysis and final reporting. You will collaborate with cross-functional teams and external partners to deliver clinical studies efficiently, on time, and within budget. The position also offers the opportunity to strengthen clinical operations practices, introduce innovative approaches to research, and support the advancement of patient care. Success requires strong project leadership, scientific understanding, and a proactive approach to risk management and continuous improvement. This is a remote opportunity within the United States, with travel to the Boston area as needed. Accountabilities: In this role, you will oversee clinical trial operations from initial protocol development through study closeout, ensuring compliance with applicable regulations and quality standards. You will work closely with internal teams and external collaborators to maintain study progress, manage risks, and improve clinical development processes. - Lead the initiation, execution, and closeout of clinical trials, ensuring compliance with Good Clinical Practice (GCP) guidelines and international regulatory requirements. - Contribute to study concept development, protocol design, feasibility assessments, and study start-up activities. - Manage strategic relationships and engagement with key collaborators and external stakeholders. - Establish and maintain clinical trial trackers covering regulatory documentation, Trial Master Files (TMFs), start-up progress, screening and enrollment, invoices, payments, and project budgets. - Contribute to Institutional Review Board (IRB), Ethics Committee (EC), and other regulatory submissions.

- Oversee TMF reviews to ensure documentation is complete, accurate, and inspection-ready. - Review clinical documentation to verify compliance with Clinical Operations standards, project-specific quality requirements, standard operating procedures (SOPs), and training guidelines. - Identify, assess, and mitigate study risks, escalating issues when necessary. - Coordinate with cross-functional teams, including Quality Assurance, Data Management, Biostatistics, Medical Writing, Safety, Clinical Supply, and Finance. - Drive the adoption of best practices and continuous improvement initiatives across clinical development. - Support data exchange, analysis, and interpretation to help generate reliable clinical evidence. Requirements: The ideal candidate combines substantial clinical trial management experience with strong operational knowledge, regulatory expertise, and the ability to lead projects across multiple functions. You should be comfortable working independently in a fast-paced environment while building productive relationships with colleagues and external partners. - Bachelor's degree in a scientific field required; an advanced scientific degree is a plus. - At least 5 years of direct clinical trial management experience in a sponsor or Contract Research Organization (CRO) setting. - In-depth knowledge of clinical trial operations, ICH guidelines, Good Clinical Practice (GCP), and other applicable regulatory requirements. - Experience directing or coordinating clinical operations team members. - Proven ability to collaborate effectively across multiple functional areas and manage complex clinical projects. - Strong project management, organizational, and time-management skills, with exceptional attention to detail.