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Job Description Summary

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 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.

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.

We are seeking a **Senior Manager, Clinical Affairs** to lead strategic initiatives within our **Advanced Patient Monitoring (APM) portfolio** , a cornerstone of our mission to improve patient outcomes through cutting-edge technology. In this role, you will oversee a high-performing clinical operations team, ensuring the successful design, execution, and monitoring of clinical trials that support regulatory compliance and product excellence.

You will play a pivotal role in shaping clinical strategies for **IDE, NSR IDE, and post-market** studies, while fostering collaboration across R&D, Regulatory Affairs, Clinical Affairs, and Key Opinion Leaders. This position demands a visionary leader with deep expertise in clinical operations, exceptional project management skills, and the ability to influence change across a global organization. If you are passionate about advancing patient care through innovative monitoring solutions and thrive in a fast-paced, cross-functional environment, we invite you to bring your expertise and leadership to our team.

Job responsibilities:

+ Manage and oversee the work of a clinical operations team and may indirectly manage cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department. Assess knowledge and/or quality gaps of clinical staff and determine appropriate training plans and/or needs

+ Oversee the planning of start-up activities (e.g., protocols, informed consents, contracts, scope of work, case report form development, training materials) with accountability for successful completion within scope of project deliverables. Maintain high level continuity of materials developed and ensure alignment with internal and external stakeholder needs (e.g., R&D, RA, Clinical Affairs, KOLs)

+ Provide strategic direction on field and remote monitoring of studies and data collection for all clinical trials, act as a study project manager, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial documentation is within parameters of study protocol, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements

+ Lead in the identification and evaluation of alignment opportunities to standardized processes across the organization and lead the implementation of course correction

+ Identify and mitigate risks due to multiple competing timeline assessments

Experience and Education required:

+ Bachelor’s degree in related sciences field.

+ 8 years progressive experience in medical device clinical trial design, planning and execution.

+ 5 years experience with hands-on clinical research monitoring.

+ 3 years of proven experience in direct people management, including coaching, mentoring, and developing high-performing teams to achieve organizational goals.

Knowledge and Skills required:

+ Proven strategic planning skills for **IDE, NSR IDE, post-market medical device** studies

+ Proven successful project management skills with meticulous attention to detail

+ Proficiency in Microsoft Office Suite (Word, PowerPoint, Outlook, Teams) with expert-level Excel skills (Pivot Tables, VLOOKUP)

+ Exceptional written and verbal communication skills, with strong interpersonal abilities including negotiation and relationship management to drive objectives

+ Expert-level knowledge of clinical operations procedures, with the ability to resolve complex, cross-functional issues and influence outcomes beyond the immediate team.

+ Extensive knowledge of human anatomy and physiology

+ Exceptional problem-solving, organizational, analytical, and critical thinking abilities, with a proven track record of delivering innovative solutions.

+ Strong leadership skills with the ability to inspire teams and drive meaningful change across the organization.

+ Ability to build strong relationships and communicate effectively across all organizational levels, proactively escalating issues to ensure timely resolution and alignment with strategic objectives.

+ Proven expertise in fostering collaboration with customers and cross-functional teams, frequently leading and influencing joint initiatives to achieve project success.

+ Ability to travel up to 20%.

Preferred qualifications:

+ Experience with preparation of clinical trial documentation and study reports preferred.

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?

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 great, 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 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.

Required Skills

Optional Skills

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Primary Work Location

USA CA - Irvine Laguna Canyon

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You (https://jobs.bd.com/en/our-commitment-to-you) .

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

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.