Senior Specialist, Clinical Research

About the role

The Senior Specialist, Clinical Research will play a key role in the planning, execution, and oversight of clinical research studies for Becton, Dickinson and Company. This position ensures studies adhere to regulatory requirements, ethical guidelines, and company standards, contributing to the development and market approval of innovative medical devices and solutions.

• Lead and support the design, development, and review of clinical study protocols, informed consent forms, and other essential study documents.
• Manage and oversee the day‑to‑day operations of assigned clinical trials, including site selection, initiation, monitoring, and close‑out activities.
• Ensure compliance with Good Clinical Practice (GCP), applicable regulatory requirements (e.g., FDA, ISO), and internal standard operating procedures (SOPs).
• Collaborate with cross‑functional teams including R&D, Regulatory Affairs, Quality Assurance, and Marketing to achieve study objectives.
• Monitor study progress, identify potential risks, and implement mitigation strategies to ensure timely completion and data integrity.
• Conduct data review, query resolution, and contribute to the analysis and interpretation of clinical trial data.
• Prepare and review clinical study reports, summaries, and other documentation for regulatory submissions and internal stakeholders.
• Participate in the selection, training, and oversight of Contract Research Organizations (CROs) and other external vendors.
• Serve as a subject matter expert for clinical research processes and provide guidance to junior team members.
• Present study updates and findings to internal and external audiences as required.

• Bachelor's degree in a scientific, biomedical engineering, or health‑related field. Master’s degree preferred.
• Minimum of 5 years of experience in clinical research, preferably within the medical device industry.
• Demonstrated knowledge of Good Clinical Practice (GCP), FDA regulations, and other relevant international standards (e.g., ISO 14155).
• Proven experience in managing clinical trials from initiation to close‑out.
• Strong understanding of clinical trial design, data collection, and statistical principles.
• Excellent written and verbal communication skills, with the ability to effectively interact with various stakeholders.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to work independently and collaboratively in a fast‑paced, complex environment.
• Strong organizational skills and attention to detail.
• Ability to travel domestically and internationally as needed (up to 20%).

• Primary
  
  Work Location:
  
  USA CA – Irvine Laguna Canyon
• Work Shift:
  
  (information not provided)

$ – $ USD Annual

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

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.