Senior Manager, Clinical Systems Architecture

Becton Dickinson Medical Devices • Sparks, NV

5d • Onsite

About The Position

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. 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

Requirements

• 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

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

Benefits

• 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 .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level