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. 

Position Summary:  

The Manager, Site Management & Monitoring is responsible for supporting BD’s business objectives by overseeing the delivery of high quality and compliant site management and monitoring activities for all clinical studies (e.g., EFS/FIH, IDE, Post-Market) sponsored by the BD Peripheral Intervention Business Unit. The Manager, Site Management & Monitoring is also responsible for the direct management and development of Site Management & Monitoring personnel. In partnership with the Director, Clinical Operations, the Manager, Site Management & Monitoring will assist with organizational planning, resource allocation as well as development and improvement of clinical procedures, processes, and templates in support of BD’s efforts towards continuous quality improvement.

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

• Perform direct functional line management for the Site Management & Monitoring team, including but not limited to, hiring, training/mentoring, resource allocation/assignments, performance and compliance assessments/reviews, recommending salaries and promotions, and implementing performance improvement plans and remedial actions, as needed.

• Manage the quality and consistency of site management & monitoring activities for all business unit projects, ensuring that the monitoring of clinical studies meets the highest standards for scientific quality, integrity and ethics and is conducted in accordance with BD global clinical procedures, study protocols, GCP and all applicable regulations.

• Allocate resources to ensure proper workload distribution and site management and monitoring for ongoing projects and initiatives.

• Procure and provide oversight for external site management & monitoring resources (e.g., consultants, CROs, etc.), as necessary, in support of business needs.

• Ensure that site management & monitoring staff meet or exceed project and functional timelines and deliverables (e.g., site qualification & start-up, enrollment, database lock, close-out, etc.).

• Develop and oversee site management & monitoring metrics reporting, including, but not limited to, monitoring visit report turnaround time, visit report quality, issue and action item management, query management, source data validation, and TMF management. Provide regular and ad hoc reporting of metrics to Clinical Affairs Leadership.

• Provide guidance, lead training assignments, identify training opportunities and resolve readiness of site management & monitoring personnel to complete functional responsibilities.

• Conduct, attend, or support co-monitoring visits, as needed, to evaluate internal & external site management & monitoring staff.

• Coach and ensure successful relationships between site management & monitoring staff, investigational site staff and cross-functional study teams.

• Review and prepare (as needed) study-specific site management & monitoring documents (e.g., Clinical Monitoring Plans, site logs, monitoring visit reports, site communications, site management trackers, etc.) to ensure operational excellence and consistency.

• Provide feedback on other clinical study documents, as needed, and serve as a resource for the BDPI Clinical Affairs team to facilitate a deeper understanding of site management & monitoring related procedures.

• Provide critical thinking and leadership support for issue escalation related to site management & monitoring. Interact with investigational sites, vendors, and other functional areas for issues, as needed. Proactively identify issues and create mitigation strategies in collaboration with leadership.

• Provide strategic direction as a subject matter expert in the assessment of relevant new technologies and global clinical procedures, as applicable.

• Provide support and allocate resources for internal or external audits/inspections and ensure resolution of audit/inspection findings related to