Title: R-514152 Clinical Safety Coordinator (Hybrid)

Location: Tempe AZ United States

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 creativity 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.

Position Summary: The Clinical Safety Coordinator is responsible for delivering high quality and compliant day-to-day operational support for the Clinical Safety team 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 operational support for Clinical Safety management activities 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 ensuring the highest standards for scientific quality, integrity and ethics are met and that these are conducted in accordance with BD global clinical procedures, study protocols, GCP and all applicable regulations.

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.

Support Trial Master File (TMF) maintenance for Clinical Safety documentation and perform study and/or site-level audits to ensure that study files are current, accurate, complete and audit-ready.

Support the Clinical Safety team with other administrative tasks (e.g., collection of study documents, Confidentiality Disclosure Agreement requests, HCP Consulting Agreements, etc.) as needed, to facilitate the conduct of the study.

Support the management of 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 partners.

Support the development and completion of study-specific Clinical Safety Plans, Medical Monitor Approval Forms, Clinical Events Committee (CEC) Charters, Data Monitoring Committee (DMC) Charters, and other safety-related study documents, as needed.

Support the reporting and escalation of BD product complaints and other events/issues that inhibit safe and effective use of BD products and negatively impact data collection.

Support safety-related interactions, training and invoicing for Medical Monitors, CEC Members, DMC Members and other Clinical Safety vendors.

Participate in and/or support 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 support for issue partner concern 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.

Required Qualifications:

Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)

Strong interpersonal and communication/presentation (oral and written) skills

Strong organizational skills, attention to detail, critical thinking and analytical skills

Able to lead and delegate multiple tasks and prioritize importance of tasks/projects

Ability to travel up to 10% (or more during peak times)

Preferred 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

Knowledge of clinical study processes and systems (eTMF, CTMS and CDMS). Prior experience with Veeva Vault preferred.

1+ years of experience with clinical safety management or medical device safety reporting

Experience with medical device studies

Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, etc.)

Education and/or Experience:

Bachelor&#39;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)

1+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology), with clinical safety management, medical device safety reporting, or in a clinical setting

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally connect with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

At BD, we prioritize on-site collaboration because we believe it feeds 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.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be phenomenal, we do what's right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

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

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.

Required Skills

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Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

Work Shift

BD - Becton, Dickinson and Company

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