Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

The CRA Manager is responsible for supporting BD’s various Business Units’ objectives by directing the delivery of high quality, timely and compliant Global Clinical Affairs (GCA) operations, on time and within budget, in the areas of program, project and resource management, and other initiatives as applicable.

The CRA Manager acts as the Site Management and Monitoring (SMM) liaison to BD’s various Business Units for the purposes of planning, implementing, and executing clinical trials and business development activities. They will develop and maintain collaborative working relationships with Project Teams and other working groups as necessary to achieve stated business objectives.

The CRA Manager is responsible for the direct management of their staff, including building and maintaining a high-performance team through a comprehensive approach to hiring, training, mentoring and development, including retention strategies and performance improvement plans as needed. The CRA Manager assists the Director, Clinical Monitoring Operations (or designee) in organizational planning, resource allocation, and oversight of global clinical operations.

The CRA Manager is expected to contribute to the development and improvement of company procedures, processes, and templates in support of BD’s efforts towards continuous quality improvement.

The primary responsibilities of the CRA Manager are to:

• Oversee clinical trial monitoring activities.

• Coordinate and assign staff and resources to ensure monitoring for ongoing projects and initiatives, including assessing the need for and procuring external resource, if necessary.

• Manage the quality and consistency of CRAs across multiple projects, ensuring that the monitoring of clinical studies meet the highest standards for scientific quality, integrity and ethics and are appropriately scaled.

• Provide guidance and mentoring to CRAs to ensure that the studies and activities are conducted in accordance with study protocols, BD Standards, GCP, and all applicable regulations.

• Ensure that CRAs meet or exceed project and functional timelines and deliverables, and that expenditures are within study budget.

• Conduct and oversee training/onboarding of CRAs regarding all SMM processes and procedures.

• Ensure CRAs complete monitoring reports within appropriate timeframe; review monitoring reports for content and provide feedback to CRAs to finalize reports as required.

• Provide CRO oversight on outsourced studies as applicable.

• Participate in the development of protocols, quality plans, CRF completion instructions, ICF templates, and other study related documents.

• Provide monitoring experience and knowledge to study project teams, who are responsible for the overall development, manufacturing, and marketing of new and modified products.

• Provide strategic direction in the assessment of relevant new technologies and procedures, as applicable. Lead the implementation and deployment of new systems and procedures across GCA.

• Interact with investigative sites, vendors, and other functional areas as project contact for clinical issues.

• Participate in Regulatory Audits and BIMO inspections, assist with audit preparation, and resource allocation.

Required Qualifications:

• Bachelor’s Degree, *Graduate Degree, *Postgraduate Degree (*Preferred, but not required)

• Ten plus (10 ) years of Field Monitoring, Site Coordinator, and/or Clinical Research experience

• People management experience, either direct or indirect (through mentoring or project assignments), is required

• Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, RAPS) required, but may be obtained while in the role.

• Strong computer skills with a proficiency with MS Windows based applications

• Strong working knowledge of Good Clinical Practices (GCP), FDA and ISO regulations, and current industry practices related to the conduct of clinical trials

• Excellent communication skills (oral and written)

• Strong organizational skills and attention to detail

• Able to manage multiple tasks and prioritize importance of assigned tasks/projects

• Proven ability to successfully work independently

• Robust experience with EDC, CTMS, and eTMF systems required

• Ability to travel 40% and more during peak times

• Demonstrated ability to work effectively on cross-functional teams

• Medical device clinical trial experience is preferred

For certain roles at BD, employment sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. 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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

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.

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