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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. 

As part of BD's Advanced Patient Monitoring (APM) portfolio, the Manager,Clinical Affairs is responsible for leading and managing clinical research activities that support product development, regulatory submissions, and commercialization. The position oversees the planning and execution of clinical studies, ensuring alignment with business objectives, compliance with global regulations, and delivery within timelines and budgets. Key responsibilities include developing study protocols and related documentation, managing budgets, coordinating data analysis and reporting, and supporting product launch initiatives. The role also involves vendor management, cross-functional collaboration, and implementation of standardized processes to ensure high-quality clinical outcomes. This position requires strong leadership, organizational skills, and a deep understanding of Good Clinical Practice (GCP) and FDA regulations.

Job Responsibilities:

• Participate on cross functional core project team to ensure clinical deliverables are aligned with Business Unit and/or corporate objectives.
• Oversee the planning and execution of clinical studies to ensure that deliverables are completed on time and within budget.
• Support regulatory submission activities globally where clinical study data is needed to show product safety and efficacy.
• Develop and manage study related documents and materials such as study protocol, investigational plans, case report forms, study manuals, monitoring plan, informed consents, investigator brochure, websites, recruitment materials and other study related tools.
• Develop and manage overall study budgets, negotiation of budgets with clinical sites, vendors, and consultants
• Coordinate the development, drafting, and submission of clinical reports, clinical study data, and Summary of Safety and Effectiveness Data. Support and provide data reviews of abstracts, manuscripts, presentations, Instructions for Use, and other materials that include study data.
• Support product launch activities as needed.
• Select and manage external vendors (including but not limited to CROs, core labs, and physician consultants) to ensure that deliverables are completed on time, within budget, and are consistent with the scope of work.
• Develop an understanding of competitive landscapes for assigned products and therapeutic areas.
• Demonstrate understanding of Business Unit general business functions, products, and procedures.
• Conduct on-site clinical monitoring/quality activities as needed.
• Interact with investigative sites, vendors, and other functional areas to ensure successful execution of a clinical trial.
• Ensure that internal and external clinical study teams fulfill their responsibilities in accordance with corporate standards, regulations, and good clinical practice.
• Oversee and review work product of project team members to ensure quality and compliance, providing training or mentoring as needed.
• Oversee appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements.
• Plan investigator and coordinator meetings and prepare and present meeting materials.
• Oversee development and management of clinical database.
• Develop and implement standardized processes and operating procedures for conducting clinical research.
• Provide direct line management for Clinical Affairs personnel as needed.

Education and Experience Required:

• Bachelor’s degree (BA/BS) in a health science field or a different field with 4+ years of experience in the medical device clinical research industry.
• 2+ years of experience managing and monitoring clinical research studies in the medical device industry.
• Strong working knowledge of GCP, FDA regulations, and current industry practices related to clinical trials.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams).

Knowledge and Skills required:

• Exceptional communication skills, both oral and written, with the ability to convey complex information clearly and persuasively.
• Strong interpersonal and organizational capabilities, fostering collaboration and driving efficiency across teams and projects.
• Proven ability to work independently and lead multiple initiatives in a fast-paced environment, demonstrating agility in overcoming challenges and delivering results.

Preferred qualifications:

• MA/MS degree in health science field preferred.
• 2+ years experience with hemodynamic monitoring devices is preferred.