Becton, Dickinson and Company

Clinical Safety Specialist

Becton, Dickinson and Company • $80K — $95K *
Tempe, AZ 85281In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Knowledge of clinical research regulations, GCP, and industry practices.
  • Proficiency with Microsoft Suite tools, including SharePoint.
  • Familiarity with clinical study processes (eTMF, CTMS, CDMS).
  • Strong interpersonal and communication skills, both oral and written.
  • Excellent organizational skills and attention to detail.
  • Ability to manage multiple tasks and prioritize effectively.
  • Willingness to travel up to 10% of the time.

Responsibilities

  • Provide Clinical Safety Management support for clinical studies.
  • Ensure quality and compliance for safety-related activities.
  • Conduct Clinical Safety monitoring activities and track reportable safety events.
  • Serve as a Clinical Safety expert for stakeholders and study site personnel.
  • Develop relationships with investigational site staff and cross-functional teams.
  • Manage study-specific tracking reports for Clinical Safety deliverables.
  • Participate in study-specific meetings and provide critical issue escalation support.

Benefits

  • Opportunities for on-site collaboration fostering innovation.
  • Flexibility in workplace arrangements based on role.
  • Support for employee wellness and work-life balance initiatives.
Full Job Description
Job Summary:

The Clinical Safety Specialist is responsible for delivering high quality and compliant Clinical Safety management for clinical studies (e.g., EFS/FIH, IDE, Post-Market) sponsored by the BD Peripheral Intervention business unit to ensure they meet the highest standards for scientific quality, integrity and ethics and are conducted in accordance with BD global clinical procedures, study protocols, GCP and all applicable regulations.

Key Job Responsibilities:
  • Provide Clinical Safety Management support for BDPI clinical studies to enable successful completion of study objectives and deliverables.
  • Ensure quality and compliance for safety-related activities performed for assigned clinical studies.
  • Conduct Clinical Safety monitoring activities for assigned clinical studies to proactively identify/review/track reportable safety events, identify safety event trends/signals, issue and address data queries, ensure timely reporting for reportable safety events (e.g., Unanticipated Adverse Device Effects, device deficiencies, etc.), address/escalate safety non-compliance issues, and verify that any corrective actions are implemented.
  • Serve as the Clinical Safety expert and resource for BD stakeholders, Investigators, and study site personnel for assigned clinical studies.
  • Develop and maintain strong relationships with investigational site staff, HCP consultants (e.g., Medical Monitors, CEC/DMC members), and cross-functional study teams to support Clinical Safety deliverables. Facilitate communication between clinical sites and BD stakeholders (e.g., PMs, CRAs), as needed.
  • Develop and manage study-specific tracking reports for Clinical Safety, as needed, to ensure Clinical Safety reporting is completed compliantly and that other Clinical Safety deliverables are completed within study-specific timelines and budgets for assigned clinical studies. Provide regular Clinical Safety status updates to relevant BD and study stakeholders.
  • Perform study and/or site-level audits of the Trial Master File (TMF) to ensure that Clinical Safety related study files are current, accurate, complete and audit-ready.
  • Develop and/or complete study-specific Clinical Safety Plans, Medical Monitor Approval Forms, Clinical Events Committee (CEC) Charters, Data Monitoring Committee (DMC) Charters, Sponsor Assessment of Event Templates, Potential U(S)ADE/Serious Health Threat Assessment Forms, Preliminary Clinical Safety Threshold Evaluation Forms, Safety Event Narratives, Financial Disclosure Forms, Potential Conflict of Interest Forms, Requests for Clinical Supplier Contract Forms, Study Training Records, Clinical Non-Compliance Escalation Forms and other essential clinical safety-related study documents, as needed.
  • Review and provide input on the development of other essential clinical study documents related to Clinical Project Management, Site Management & Monitoring, Clinical Data Management, Clinical Statistics, Clinical Product Management and Clinical Supplier Management.
  • Report and escalate BD product complaints and other events/issues that inhibit safe and effective use of BD products and negatively impact data collection and study performance to BD stakeholders in accordance with established clinical study procedures, regulations and company policies.
  • Manage safety-related interactions, training and invoicing for Medical Monitors, CEC Members, DMC Members and other Clinical Safety vendors.
  • Participate in, support and/or lead study-specific meetings including, but not limited to Safety Event Trending Meetings, CEC Adjudication/Meetings, DMC Meetings, safety-related study team meetings, and vendor meetings.
  • Provide critical thinking and support for issue escalation related to Clinical Safety. Interact with investigational sites, vendors, and other functional areas for issues, as needed. Proactively identify issues and create mitigation strategies in collaboration with Clinical Project Management and other leadership.
  • Provide support for internal or external audits/inspections and ensure resolution of audit/inspection findings related to Clinical Safety activities.
  • Support continuous improvement activities/initiatives and sharing of best practices, including development of Clinical Safety tools and resources.
  • Mentor Clinical Safety personnel and conduct evaluations for other Clinical Safety personnel, as needed. Identify performance issues and training opportunities and communicate with Clinical Safety leadership, as needed.


Required Qualifications:
  • Knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies
  • Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)
  • Proficient knowledge of clinical study processes and systems (eTMF, CTMS and CDMS)
  • Strong interpersonal and communication/presentation (oral and written) skills
  • Strong organizational skills, attention to detail, critical thinking and analytical skills
  • Able to manage and delegate multiple tasks and prioritize importance of tasks/projects
  • Ability to travel up to 10% (or more during peak times)


Preferred Qualifications:
  • Prior experience with clinical studies related to peripheral vascular diseases, end-stage kidney disease and/or oncology
  • Experience with medical device studies
  • Proficiency with Veeva Vault CTMS, CDMS and eTMF
  • Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, etc.)


Education and Experience:
  • Bachelor's Degree (BS/BA) in life sciences, nursing, a related healthcare field equivalent OR a related certification in cardiology or radiology or equivalent combination of training and experience (MA/MS preferred)
  • 2+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology)
  • 2+ years of experience with clinical safety management or medical device safety reporting


At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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.

Primary Work Location
USA AZ - Tempe Headquarters

Additional Locations

Work Shift

About Becton, Dickinson and Company

BD is a global technology company that provides diagnostics and technologies for frontliners. Through their solutions and services, they assist scientists in detecting diseases and advanced researchers' on developing diagnoses and therapeutics. BD was established in 1897 by Farleigh Dickinson and Maxwell Becton in East Rutherford, New Jersey.

Becton, Dickinson and Company Careers

Join the innovative world of Becton, Dickinson and Company (BD), a global medical technology company that is actively seeking driven, dedicated professionals to join our team. At BD, we are committed to advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. This commitment provides the foundation for a workplace where you can engage in meaningful work and where job opportunities abound.

Work You’ll Do

At BD, you will be part of a culture that values diversity, leadership, and innovation. Our team members are empowered to lead and inspire from day one. Join us and contribute to our mission of advancing the world of health through your professional skills and personal passion.

Transform Your Career

BD offers a unique position in the marketplace that combines industry expertise, leadership in medical innovation, and a collaborative culture to help you grow your career. Whether you are looking for an entry-level position or a more senior role, we provide the tools and support for your professional growth through comprehensive training and development programs.

Innovative Work Environment

Our team at BD is composed of more than 65,000 associates across the globe. These dedicated professionals work at the intersection of technology and healthcare, where they drive innovation and ensure that we stay ahead in a rapidly evolving industry. By joining BD, you will work alongside some of the brightest minds in the industry.

Internship and Employment Opportunities

Start your career with BD through our internship programs or dive straight into a full-time position. We offer a range of opportunities that allow you to explore different areas of our business and find a path that aligns with your career goals. Our hiring process is designed to be transparent and engaging, ensuring that all candidates—whether submitting a resume for an internship or a senior position—feel valued and informed.

Benefits and Culture

BD is proud to offer competitive benefits that support the health, well-being, and financial security of our employees and their families. From comprehensive health insurance to employee wellness programs and flexible working arrangements, we prioritize the well-being of our team members. Our inclusive culture encourages networking, continuous learning, and the sharing of ideas in a diverse and welcoming environment.

Join Our Team

Explore the job opportunities at BD and discover how your expertise can help shape the future of healthcare. Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players.

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Whether you're preparing for your first interview or looking to advance into a leadership role, BD offers career paths that foster continuous growth and innovation. Join us in our mission to improve medical outcomes and enhance patient care worldwide.

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At Becton, Dickinson and Company, we are more than just a company; we are a community that is dedicated to making a difference in the lives of people all around the world.
Learn more about Becton, Dickinson and Company
Size
75,000 employees
Market Cap
$72 billion
Industry
Healthcare
Net Income
$1.6 billion
Founded
1897
5 Year Trend
+9.3%
Revenue
$18.2 billion
NASDAQ
BDX
* Ladders Estimates

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