Senior Manager​/Associate Director, Clinical Operations

Job Title:Senior Manager/Associate Director, Clinical Operations

Job Number: 37207

Location: Boston,MA

Job Description

Provide leadership and oversight of clinical operations to ensure clinical programs and trials are effectively planned, executed, and delivered in compliance with regulatory and quality requirements. Accountable for managing study timelines and budgets, developing study-related documentation, coordinating relationships with study sites and CROs, overseeing trial activities, and proactively identifying project risks with appropriate mitigation strategies in place.

Operational Leadership

• Provide end-to-end oversight of clinical studies from start-up through close-out, ensuring delivery against scope, timelines, budgets, and quality standards.

• Independently manage clinical trials, including studies outsourced to Contract Research Organizations (CROs).

• Contribute to the development of clinical protocols and related documentation, including literature reviews, clinical study reports, annual reports, risk–benefit assessments, informed consent forms, and other required materials.

• Develop and oversee comprehensive study plans (e.g., training, recruitment, monitoring, safety, and other study-specific plans), with accountability for data management oversight.

• Lead the selection, onboarding, and daily management of CROs and other external partners supporting assigned clinical trials.

• Oversee and monitor all outsourced and collaborative activities involving CROs, core laboratories, and internal and external stakeholders.

• Design and implement operational strategies, processes, tools, and performance metrics to enhance efficiency and execution across clinical programs.

• Ensure adherence to Good Clinical Practice (GCP), applicable regulatory requirements, and internal standard operating procedures (SOPs).

• Lead, mentor, and support junior clinical operations staff, fostering high performance and professional development.

• Serve as the primary liaison for internal leadership, study sites, and external partners.

• Maintain regular cross-functional communication with R&D, Regulatory, Marketing, and other key departments.

• Prepare and deliver timely clinical trial updates to internal stakeholders.

• Develop, maintain, and update project plans, risk registers, issue logs, and mitigation strategies.

• Drive timely study execution, including site initiation, enrollment, data collection, query resolution, and database lock activities.

• Provide regular reporting on study progress, operational performance, and key risks to senior leadership.

• Drive continuous improvement initiatives by advancing operational processes, refining SOPs, and promoting best practices across clinical operations.

• Ensure the accuracy, reliability, and overall quality of clinical data and operational outputs.

• Bachelor’s degree in life sciences, healthcare, or a related field.

• More than 10 years of experience leading clinical trials within the medical device sector, with a preference for implantable device studies.

• Demonstrated experience managing teams, including direct reports and/or cross-functional project teams.

• Solid understanding of Good Clinical Practice (GCP) and both U.S. and international clinical trial regulatory requirements.

• Strong capabilities in strategic planning, project management, negotiation, and operational execution.

• Proven leadership skills with excellent communication and the ability to effectively engage diverse stakeholders.