Job Description

Job Summary:

The Sr. Clinical Quality Specialist is responsible for leading and executing clinical quality oversight activities across Terumo’s clinical trials. This role ensures compliance with study protocols, of ISO 14155 / 13485 / 14971, 21 CFR 50/56/812, and ICH-GCP and applicable regulatory requirements, while driving continuous improvement in clinical quality systems and processes.

Key responsibilities include planning and conducting audits, managing vendor quality performance, leading risk mitigation strategies, and serving as a subject matter expert for inspection readiness. The Sr. Clinical Quality Specialist collaborates cross-functionally to resolve complex quality issues, develop quality metrics and dashboards, and support the creation of training programs and controlled documents. This role operates with a high degree of independence and provides strategic input to clinical teams to ensure data integrity, regulatory compliance, and patient safety throughout the study lifecycle.

Job Details:

Leading the development and execution of Clinical Risk Management Plans and Clinical Quality Plans for studies

Conducting audits of clinical sites and eTMF to ensure compliance with ICH-GCP and internal procedures. Track and manage Audit Deficiency Records, ensuring timely approval and effectiveness verification.

Developing and reporting of Clinical Quality Metrics and KPIs across studies

Performing vendor management, including audits and issue escalation for clinical suppliers

Advising clinical teams on handling noncompliance and quality issues during study execution

Collaborating with stakeholders to lead revisions of processes and documents within the change control process for new/revised regulatory standards impacting clinical.

Developing training and tools for inspection readiness as well as supporting external inspections.

Organizational Impact:

The Clinical Quality Specialist directly contributes to Terumo’s clinical trial excellence by ensuring regulatory compliance, mitigating risks, and enhancing process efficiency. Decisions made by the Sr. Clinical Quality Specialist influence study timelines, data integrity, and regulatory outcomes, supporting Terumo’s mission to improve patient care through innovation. Their efforts directly impact data integrity and regulatory readiness across clinical studies.

Communication & Influence:

The Clinical Quality Specialist communicates regularly with internal peers, clinical project teams, clinical Research & Operations, Regulatory Affairs, and Quality Assurance. The role ensures protocol compliance and maintains data quality through oversight. They exchange information, educate internal staff, and influence operational decision-making through risk assessments, audit outcomes, and quality metrics reporting.

Innovation & Complexity :

The Sr. Clinical Quality Specialist addresses a wide range of complex challenges related to clinical quality data, vendor oversight, regulatory compliance, and risk management. This role requires analytical problem solving and adaptability, as it involves solving routine and non-routine problems, some of which demand customized solutions and critical analysis. The specialist contributes to the development and refinement of quality tools, dashboards, and guidance documents, while also driving improvements to procedures and controlled documents.

Leadership & Autonomy :

The Clinical Quality Specialist role does not have people management responsibilities. This role navigates ambiguity in evolving regulatory landscapes and proactively adapts internal processes to meet new standards and industry trends. This role provides mentorship and technical guidance to junior CR&O staff and clinical teams. Makes autonomous decisions on quality-related matters within clinical studies with input and consideration from the Clinical Quality Manager and Clinical Research & Operations Director.

Position Requirements:

Knowledge, Skills and Abilities (KSAs):

• Deep understanding of ISO 14155 / 13485 / 14971, 21 CFR 50/56/812, ICH-GCP, and FDA regulations
• Strong auditing and risk management skills. Prior experience with auditing and risk management.
• Proficient in EDC and CTMS systems (e.g.,Veeva), MS Office tools.
• Excellent time management, prioritization, communication, negotiation, and problem-solving abilities
• Ability to analyze and present quality metrics and KPIs
• Ability to manage projects and process improvement initiatives
• Understanding of Clinical Monitoring, IRBs, and Safety oversight

Exhibits adaptability and takes initiative in supporting departmental projects and initiatives, c contributing effectively during and between studies, as required.

Background Experiences:

• Bachelor’s degree in life sciences, nursing, or related field required and minimum 5 years of experience in clinical quality assurance or clinical quality operations or a combination of relevant experience, training, and education.
• Experience conducting audits and managing clinical vendors required.

Certification in auditing or clinical research (e.g., CQA, RQAP-GCP, CCRA) required.

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