Senior Clinical Research Specialist

BD; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

BD is seeking a Senior Specialist, Clinical Research to lead and oversee clinical studies in support of medical devices development and regulatory submissions. You will ensure studies comply with GCP, FDA regulations, and ISO standards while partnering with R&D, Regulatory, QA, and Marketing to achieve program goals.

In this role, you will design study protocols, manage trial operations, monitor data integrity, and review reports for regulatory submissions.

Qualifications

• Bachelor's degree in a scientific or health-related field; Master's preferred.
• 5+ years in clinical research, preferably medical devices.
• GCP knowledge, FDA regulations, ISO 14155 understanding.
• Experience managing clinical trials from initiation to close-out.
• Strong communication with cross-functional teams.
• Proficiency with CTMS and EDC systems.

Responsibilities

• Lead design, development, and review of study protocols and consent forms.
• Oversee day-to-day trial operations: site selection, initiation, monitoring, close-out.
• Ensure compliance with GCP, regulatory requirements and SOPs.
• Collaborate with R&D, Regulatory, QA, and Marketing to meet objectives.
• Monitor progress, identify risks, and implement mitigation strategies.
• Conduct data review, query resolution, and contribute to analysis.
• Prepare study reports and regulatory submission documents.
• Oversee CROs and external vendors.
• Serve as SME and guide junior team members.
• Present updates to internal and external stakeholders.

Skills

GCP

FDA regulations

CTMS

EDC

Cross-functional collaboration

Project management

Travel (up to 20%)

Education

Bachelor's degree in scientific/health field

Master's degree preferred

Tools

CTMS

EDC systems

Job description

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

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.

Key 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%).

Preferred Qualifications

• Master's Degree
• Experience working in new product development (NPD)

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.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

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.

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.

Primary Work Location

USA CA - Irvine Laguna Canyon

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$105,500.00 - $168,800.00 USD Annual