Job Description Summary

Key partner in transforming Global Medical Affairs within BD by directing the development of innovative and interoperable clinical systems that drive a robust evidence generation program. Architect object-focused clinical systems to simplify and transform clinical operations and clinical data management.

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. 

Overview:

• Deliver scalable future-state clinical systems that deliver inspection-ready new product development (NPD) to commercialization capabilities

• Lead and oversee the architecture, implementation, and strategic direction of Global Clinical Affairs clinical systems, ensuring milestones, budgets, and system requirements are met

• Provide thought leadership for and drive the evolution of innovative clinical system solutions by increasing efficiency through automation and interoperability, improving analytics capabilities, and enhancing end-user adoption

• Steward architecture between clinical study teams and clinical systems to optimize clinical trial execution and reduce timelines

Job Responsibilities:

• Identify and assess clinical system procurements, enhancements, and interoperability to harmonize data flow from NPD to commercialization

• Streamline clinical operations and achieve a continual state of inspection readiness

• Lead strategic and collaborative partnerships with external service providers and key stakeholders to align clinical systems with business initiatives and budgets

• Be a change agent by stewarding and pioneering transformational projects that focus on automation, improved workflows, and interoperability

• Consult and collaborate with SMEs to build bi-directional data connections and object-based configurations utilizing vendor best practice approaches

• Partner with clinical quality and compliance to leverage clinical system design to mitigate risk and ensure audit readiness

• Lead communication strategy to enhance end-user and key stakeholder engagement

• Drive master data cleanup to identify and replace manual entry object records with interoperable data connections where possible; unify clinical data capture

• Oversee end-to-end clinical system functions, including planning, design, configuration, and day-to-day management

• Be a key partner in the development of Global Clinical Affairs’ digital strategy and technology roadmaps

• Work with cross-functional leaders to define and enhance methodologies and practices for clinical system lifecycle management

• Drive clinical system team process optimization to encourage utilization of data loader, API, and business logic to bulk create, update, and delete clinical system data

• Accountable to ensure projects and operations meet industry standards and regulations through the establishment of controls, measures, and thorough development of a quality-conscious culture

• Initiate continuous clinical system improvement efforts, identify and develop best practices, and enforce standardization when appropriate

• Accountable for clinical system validation and change control management

• Perform all clinical system design and improvement workstreams utilizing a risk-based approach

• Provide guidance, leadership, and mentoring to cross-functional Global Clinical Affairs colleagues

Required Skills/Experience:

• Bachelor’s degree

• Veeva Vault Platform Certified White Belt (minimum of 500 hours of direct experience architecting, implementing, and managing clinical systems)

• Project Management Professional certification

• Direct experience managing clinical trials

• 5+ years of proven experience in clinical operations

• 5+ years of proven experience in clinical system architecture and management

Technical experience required:

• Expert-level proficiency in configuring and architecting all facets of Veeva systems, including security, documents, objects, lifecycles, workflows, reporting, VQLs, and integrations (both Vault to Vault and external to Vault).

• Experience in performing data transformations using business intelligence tools (e.g., Power Query) to efficiently clean, manipulate, and analyze data

• Strong familiarity with APIs, including creating and managing API collections, running tests, and understanding JavaScript and JSON for interacting with and analyzing API data

Advanced knowledge required to be successful in this role:

Privacy:

• HIPAA
• GDPR

Industry standards and regulations:

• 21 CFR Part 11
• ICH-GCP guidelines
• DIA TMF Reference Model
• GAMP 5
• SDLC

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 minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$143,900.00 - $237,600.00 USD Annual