Manager Clinical Monitoring Operations

About the role

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.

Requirements

• 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

Benefits

Additional Information

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. 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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