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BD (Becton, Dickinson and Company) Sr. Clinical Quality & Compliance Specialist (Remote USA) in Franklin Lakes, New Jersey

Job Description Summary

The Sr. Clinical Quality and Compliance Specialist is responsible for supporting the Global Clinical Affairs (GCA) 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

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

The Sr. Clinical Quality and Compliance Specialist is responsible for supporting the Global Clinical Affairs (GCA) 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 Quality and Compliance (CQC) organization and clinical study teams

  • Proactively identify compliance issues and support the associated teams to work towards an effective resolution

  • Identify and escalate significant compliance issues to the Director of Clinical Quality and Compliance and other relevant leadership, including the assessment of serious breaches

  • Stakeholder 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 CQC representative in GCA-wide 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

  • Minimum 5 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

  • 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:

  • Effective communication skills both verbal and written

  • Ability to work independently with minimal supervision and accountable for managing multiple program objectives concurrently

  • High attention to detail and accuracy

  • Strong interpersonal 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

For many roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, 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 any other protected status.

PDN

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

USA AZ - Tempe Headquarters, USA CA - San Diego Bldg A&B, USA CA - San Jose, USA DC - Washington, DC, USA FL - Miami, USA IL - Vernon Hills, USA MA - Woburn, USA MD - Sparks - 7 Loveton Circle, USA MO - St Louis, USA NE - Holdrege, USA RI - Warwick, USA SC - Moncks Corner, USA TX - San Antonio, USA UT - Salt Lake City, USA UT - Sandy, USA WA - Seattle

Work Shift

NA (United States of America)

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, 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 any other protected status.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, 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 any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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