Manager Clinical Monitoring Operations
BD
Unknown, Maryland
Full-Time
Competitive
RemoteManager
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.
Summary:
The Manager for Monitoring Operations role is responsible for leading and overseeing clinical study monitoring activities across the global portfolio, ensuring the highest standards of quality, compliance, and execution. This individual will provide strategic and operational leadership to monitoring teams, drive continuous improvement, and serve as a subject matter expert in site management and monitoring practices.
Responsibilities:
Oversee clinical trial monitoring activities across the full portfolio, ensuring alignment with program and organizational objectives.
Lead and manage a team of Clinical Research Associates (CRAs), providing direction, coaching, and performance oversight.
Allocate and optimize resources across studies, including assessment and engagement of external vendors as needed.
Ensure monitoring activities are conducted in compliance with Good Clinical Practice (GCP), ISO 14155, and all applicable regional and local regulations.
Drive execution to meet or exceed study timelines, deliverables, and quality expectations.
Collaborate cross-functionally with core product development teams to support overall clinical and business objectives.
Provide proactive issue identification, critical thinking, and escalation support during study execution.
Review and approve monitoring plans and ensure appropriate risk-based monitoring strategies are applied.
Establish and maintain high standards for scientific quality, data integrity, and ethical conduct across all studies.
Partner with Quality teams to identify and implement process improvements and best practices.
Lead or contribute to the development of functional job aids, SOP enhancements, and training materials.
Serve as a subject matter expert (SME) in monitoring and site management, providing input into study design and execution strategies.
Oversee hiring, onboarding, training, and ongoing development of CRA staff.
Actively manage performance, including goal setting, feedback, and career development planning for direct reports.
Foster strong relationships between CRAs, investigational sites, and internal stakeholders.
Review and approve CRA expenses and ensure adherence to company travel and expense policies.
Minimum Qualifications:
Bachelors degree .
Minimum of 7 years of clinical trial experience
Preferred Skills/Knowledge:
Experience in medical devices and/or in vitro diagnostics (IVD)
Demonstrated leadership experience, including direct or indirect oversight of clinical monitoring teams.
Strong knowledge of global clinical research regulations and standards, including ICH GCP and ISO 14155.
Excellent communication, organizational, and problem-solving skills, with the ability to effectively influence cross-functional stakeholders.
Proven ability to manage multiple priorities and deliver results in a fast-paced, deadline-driven environment.
Strong interpersonal and collaboration skills, with experience working in cross-functional and virtual team environments.
Demonstrated ability to lead change, foster team cohesion, and drive continuous improvement initiatives.
High degree of professionalism, integrity, and sound ethical judgment.Growth-oriented mindset with the ability to adapt to evolving business needs.
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.
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.
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.
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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.
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