BD
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Job Summary The Sr. Manager, Clinical Quality serves as a key leader within the Medical Affairs organization, responsible for overseeing a team dedicated to ensuring regulatory compliance, Good Clinical Practice (GCP), subject safety, and data integrity across clinical research activities. Reporting to the Sr. Director, Clinical Affairs, this role encompasses strategic leadership, operational oversight, and continuous improvement of clinical quality processes throughout the study lifecycle.
Ideal Candidate The ideal candidate will demonstrate proven leadership capabilities with a strong track record of driving team success and achieving organizational goals. They will possess a natural aptitude for mentoring and developing talent, while maintaining independence and effectiveness in navigating uncertainty. This individual will be highly skilled in managing multiple concurrent program objectives and will exhibit a commitment to continuous learning. Clear and effective communication across diverse audiences is essential, as is the ability to build strong relationships and collaborate with internal and external stakeholders. The candidate should maintain exceptional attention to detail and accuracy, thrive in team-oriented environments, and display strong interpersonal skills. Experience driving process improvements is highly valued.
Responsibilities
Provide direct line management and performance oversight for the Clinical Quality team, including resource planning, project timeline adherence, and compliance with applicable regulations and internal procedures.
Support and empower the Clinical Quality team in driving the strategic application of regulatory standards, industry guidelines, and internal processes across all phases of clinical study conduct (planning, execution, and closeout).
Collaborate with study teams to proactively influence clinical operations and ensure compliance; provide guidance to remediate non‑compliance and restore alignment with regulatory and organizational expectations.
Maintain oversight of Corrective and Preventive Action (CAPA) processes and audit responses related to clinical research.
Oversee Clinical Quality Management System and drive training/compliance.
Establish and promote mechanisms for sharing best practices and lessons learned across the organization.
Identify and escalate significant compliance risks to Medical Affairs leadership, ensuring timely and effective resolution through appropriate remediation strategies.
Manage performance development for direct reports, including ongoing feedback, formal reviews, and succession planning.
Oversee recruitment, onboarding, and ongoing training of Clinical Quality staff, ensuring alignment with evolving organizational needs.
Review and approve team‑related expenses, ensuring compliance with corporate travel and expense policies.
Minimum Requirements
Bachelor’s degree.
7 years of experience in a quality role within clinical trials (e.g., clinical quality, clinical compliance, or clinical auditing).
Preferred Experience
7 years of experience in a quality role within diagnostic clinical trials.
2 years of experience as a direct people leader.
2 years of experience in clinical monitoring or study management.
Mastery of MedTech regulations and standards (e.g., 21 CFR 812, 50, 54, 56, ISO 14155, ISO 20916, ISO 13485, ISO 14971, EU MDR/IVDR, China FDA, JGCP, ICH E6).
Benefits At BD, we prioritize on‑site collaboration to foster creativity, innovation, and effective problem‑solving. For most roles, a minimum of 4 days of in‑office presence per week is required, though flexibility and work‑life balance are also valued.
Legal and Equal Opportunity Statement Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or other legally‑protected characteristics.
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Job Summary The Sr. Manager, Clinical Quality serves as a key leader within the Medical Affairs organization, responsible for overseeing a team dedicated to ensuring regulatory compliance, Good Clinical Practice (GCP), subject safety, and data integrity across clinical research activities. Reporting to the Sr. Director, Clinical Affairs, this role encompasses strategic leadership, operational oversight, and continuous improvement of clinical quality processes throughout the study lifecycle.
Ideal Candidate The ideal candidate will demonstrate proven leadership capabilities with a strong track record of driving team success and achieving organizational goals. They will possess a natural aptitude for mentoring and developing talent, while maintaining independence and effectiveness in navigating uncertainty. This individual will be highly skilled in managing multiple concurrent program objectives and will exhibit a commitment to continuous learning. Clear and effective communication across diverse audiences is essential, as is the ability to build strong relationships and collaborate with internal and external stakeholders. The candidate should maintain exceptional attention to detail and accuracy, thrive in team-oriented environments, and display strong interpersonal skills. Experience driving process improvements is highly valued.
Responsibilities
Provide direct line management and performance oversight for the Clinical Quality team, including resource planning, project timeline adherence, and compliance with applicable regulations and internal procedures.
Support and empower the Clinical Quality team in driving the strategic application of regulatory standards, industry guidelines, and internal processes across all phases of clinical study conduct (planning, execution, and closeout).
Collaborate with study teams to proactively influence clinical operations and ensure compliance; provide guidance to remediate non‑compliance and restore alignment with regulatory and organizational expectations.
Maintain oversight of Corrective and Preventive Action (CAPA) processes and audit responses related to clinical research.
Oversee Clinical Quality Management System and drive training/compliance.
Establish and promote mechanisms for sharing best practices and lessons learned across the organization.
Identify and escalate significant compliance risks to Medical Affairs leadership, ensuring timely and effective resolution through appropriate remediation strategies.
Manage performance development for direct reports, including ongoing feedback, formal reviews, and succession planning.
Oversee recruitment, onboarding, and ongoing training of Clinical Quality staff, ensuring alignment with evolving organizational needs.
Review and approve team‑related expenses, ensuring compliance with corporate travel and expense policies.
Minimum Requirements
Bachelor’s degree.
7 years of experience in a quality role within clinical trials (e.g., clinical quality, clinical compliance, or clinical auditing).
Preferred Experience
7 years of experience in a quality role within diagnostic clinical trials.
2 years of experience as a direct people leader.
2 years of experience in clinical monitoring or study management.
Mastery of MedTech regulations and standards (e.g., 21 CFR 812, 50, 54, 56, ISO 14155, ISO 20916, ISO 13485, ISO 14971, EU MDR/IVDR, China FDA, JGCP, ICH E6).
Benefits At BD, we prioritize on‑site collaboration to foster creativity, innovation, and effective problem‑solving. For most roles, a minimum of 4 days of in‑office presence per week is required, though flexibility and work‑life balance are also valued.
Legal and Equal Opportunity Statement Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or other legally‑protected characteristics.
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