Manager, Site Management & Monitoring (CRA Manager) - Hybrid
Becton Dickinson NA

Job Info

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Job Description Summary
As Manager, Site Management & Monitoring, you will be 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 Clinical Operations leadership, 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.

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.

Primary 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 compliance 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, manage training assignments, identify training opportunities and determine readiness of site management & monitoring personnel to complete functional responsibilities.
• Conduct, attend, or support 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 site management & monitoring activities and staff.
• Review/approve expenses for site management & monitoring personnel and ensure compliance with company policies.
• Support continuous improvement activities/initiatives and sharing of best practices, including development of site management & monitoring tools and resources.

About You:

• Minimum bachelor's Degree (BS/BA) in life sciences or equivalent combination of training and experience (MA/MS preferred)
• Minimum 7+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology)
• Minimum 5+ years of experience with site management & monitoring or managing clinical projects
• Proficient working knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies
• Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)
• Proficient knowledge of clinical study processes and systems (eTMF, CTMS and CDMS)
• Strong interpersonal and communication/presentation (oral and written) skills
• Strong organizational skills, attention to detail, critical thinking and analytical skills
• Able to manage and delegate multiple tasks and prioritize importance of tasks/projects
• Ability to lead teams to translate issues into actions, make decisions and influence outcomes
• Ability to travel up to 25% (or more during peak times)

Preferred Qualifications:

• Prior experience with clinical studies related to peripheral vascular diseases, end-stage kidney disease and/or oncology
• 1+ years of experience with direct people management
• Experience with medical device studies
• Proficiency with Veeva Vault CTMS, CDMS and eTMF
• Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, etc.)

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

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/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.

Primary Work Location
USA AZ - Tempe Headquarters

Additional Locations

Work Shift

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