Job Description Summary

The Principal Clinical Quality Specialist is responsible for supporting the Global Clinical Research organization. This role will focus on ensuring that regulatory compliance, GCP, subject safety, and data integrity are maintained while also encouraging innovative research solutions. Partners with clinical study teams in a way that fosters open and trusting dialogues.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

The Principal Clinical Quality Specialist is responsible for supporting the Global Clinical Research organization. This role will focus on ensuring that regulatory compliance, GCP, subject safety, and data integrity are maintained while also encouraging innovative research solutions. Partners with clinical study teams in a way that fosters open and trusting dialogues.

KEY RESPONSIBILITIES:

• Experienced clinical quality and compliance professional with a focus on supporting, guiding, and teaching clinical study teams at every stage in the clinical study lifecycle (i.e., planning, execution, closeout)

• Drives partnership with project, program, and functional managers by acting as a direct link between the Clinical Research Quality organization and clinical study teams

• Proactively identify compliance issues and lead the associated teams to an effective resolution

• Serve as a strategic partner with stakeholders in relation to ongoing risk assessment of clinical trial activity

• Identify and escalate significant compliance issues to the Senior Manager of Clinical Quality and Compliance and other relevant leadership, including the assessment of serious breaches; ensure the completion of appropriate remediation activities

• Accountable to develop and drive change management in assigned areas of focus to ensure continuous process improvement

• Lead clinical study teams throughout the audit and CAPA response processes including strong root cause analysis and effective corrective/preventive actions

• Attend functional study team meetings and actively address ad hoc business unit needs and issues

• Review key study documents (e.g., Clinical Investigation Plans, Investigator’s Brochure, informed consents, study-specific risk management documentation) to ensure compliance with regulations, standards, and internal processes

• Serve as Clinical Quality representative in company-wide clinical research initiatives

• Support Vendor Management in vendor qualification activities, as needed, and in the resolution of vendor compliance issues and CAPAs

• Support regulatory inspections (e.g., BIMO) at clinical sites and sponsor, including inspection prep activities

• Share quality topics and lessons learned to the organization

QUALIFICATIONS:

• Bachelor’s Degree preferred.

• Minimum 7 years’ experience in clinical research required

• Prior work experience in a clinical quality, clinical compliance, or clinical auditing role

• Prior experience in study management or monitoring in investigational medical device or diagnostic trials preferred

• Advanced knowledge of and experience with 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)

• Knowledge and understanding of clinical development programs and clinical trial processes as well as quality management systems and quality control tools

• Clinical research certification preferred

PERSONAL CHARACTERISTICS:

• Demonstrated leadership competencies

• Servant leader with strong mentoring capabilities

• Ability to work autonomously and manage through ambiguity

• Able to be accountable for managing multiple program objectives concurrently

• Effective communication skills both verbal and written

• Establishes rapport and collaborates with other (internal and external) partners; builds constructive and effective relationships

• High