BD Nogales Norte · 1 day ago
Senior Manager, Clinical Systems Architecture
Sparks, MD
Part-time
Onsite
Senior Level
$144K/yr - $238K/yr
5+ years expBD is one of the largest global medical technology companies in the world, seeking a Senior Manager for Clinical Systems Architecture. The role involves directing the development of innovative clinical systems to enhance clinical operations and data management, ensuring compliance and efficiency in clinical trials.
Consumer Goods
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
Qualification
Required
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
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: HIPAA, GDPR
Industry Standards And Regulations: 21 CFR Part 11, ICH-GCP guidelines, DIA TMF Reference Model, GAMP 5, SDLC
Benefits
Valuable, competitive package of compensation and benefits programs
Company
BD Nogales Norte
Somos una empresa multinacional dedicada a la manufactura de dispositivos de uso médico a través de los cuales seguimos impulsando el mundo de la salud.
1001-5000 employees
H1B Sponsorship
BD Nogales Norte has a track record of offering H1B sponsorships. Please note that this does not
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Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Late StageCompany data provided by crunchbase