Job title: Sr. Clinical Quality & Compliance Specialist (Remote USA)
Job description: 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.
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.
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
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
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 certain 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, testing for COVID-19 may be available and/or required. 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.
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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.
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)
Location: Franklin Lakes, NJ
Job date: Sun, 14 Aug 2022 00:49:10 GMT