Job Description Summary

The Sr. 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 Sr. 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 research quality professional with a focus on supporting, guiding, and instructing 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 support the associated teams to work towards an effective resolution
• Identify and advance compliance issues to the Senior Manager of Clinical Quality and other relevant leadership, including the assessment of serious breaches
• Partner for continuous process improvement
• Engage clinical study teams throughout the audit and CAPA response processes including the development of 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
• Support regulatory inspections (e.g., BIMO) at clinical sites and the sponsor
• Share quality topics and lessons learned to the organization
• 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 required, preferably in the life sciences, advanced degree preferred
• Demonstrated ability 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
• Knowledge of and experience with MedTech regulations and standards (e.g., 21 CFR 812, 50, 54, 56, ISO 14155, ISO 20916, EU MDR/IVDR)
• 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

• Effective communication skills both verbal and written
• Ability to work independently with minimal direction and accountable for handling multiple program objectives concurrently
• High attention to detail and accuracy
• Strong social skills with the ability to work well with teams
• Servant leader with a heart of a teacher
• Establishes rapport and collaborates with other (internal and external) partners; builds constructive and effective relationships
• Knowledgeable in effective training techniques that engage learners
• Multi-disciplinary knowledge across functional areas

Total Base Pay Range: $101 000,00 - $166 600,00 USD Annual

For certain roles at BD, employment is contingent upon the Company