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.

Responsibilities

• 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.
• Minimum Education and Experience 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%).
• Why Join Us?
• We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
• To learn more about BD visit https://bd.com/careers .

Benefits

Additional Information

We are the people who give possibilities purpose 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 imagination 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. Job Description

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