Clinical Safety Lead for Medical Device Studies

Becton, Dickinson and Company; Tempe (AZ); On-site; USD 95,000 - 125,000; Full time

Job summary

Becton, Dickinson, and Company (BD) seeks a Clinical Safety Specialist to manage safety activities for BD Peripheral Intervention clinical studies, ensuring GCP compliance and regulatory adherence. The role involves monitoring safety events, preparing safety plans, and collaborating with investigators, monitors, and study teams to maintain data quality and patient safety.

Responsibilities include safety reporting, event trend analysis, and audits of TMF files, with an emphasis on strong

Qualifications

• Knowledge of domestic and international clinical research regulations and guidelines, GCP and current industry practices.
• Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint).
• Proficient knowledge of clinical study processes and systems (eTMF, CTMS and CDMS).

Responsibilities

• Provide Clinical Safety management support for BDPI studies to ensure objectives/deliverables.
• Conduct safety monitoring to identify/reportable safety events and trends.
• Develop and maintain study-specific Clinical Safety Plans and related forms.
• Audit TMF and ensure safety-related files are audit-ready.
• Lead safety meetings and communications with BD stakeholders.

Skills

Clinical safety management

GCP knowledge

Regulatory knowledge

Communication skills

Project coordination

Education

Bachelor’s degree in life sciences or related field

Related certification (cardiology or radiology)

Tools

Veeva Vault CTMS

eTMF/CDMS

CTMS systems

Microsoft Office

Job description

Becton, Dickinson, and Company (BD) seeks a Clinical Safety Specialist to manage safety activities for BD Peripheral Intervention clinical studies, ensuring GCP compliance and regulatory adherence. The role involves monitoring safety events, preparing safety plans, and collaborating with investigators, monitors, and study teams to maintain data quality and patient safety.

Responsibilities include safety reporting, event trend analysis, and audits of TMF files, with an emphasis on strong