Senior Engineer Enabling Analytics & System Excellence (Clinical Trial Management Solutions) jobs in United States
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Johnson & Johnson · 1 month ago

Senior Engineer Enabling Analytics & System Excellence (Clinical Trial Management Solutions)

Johnson & Johnson is a leader in healthcare innovation dedicated to developing treatments and pioneering solutions for complex diseases. The Senior Engineer, Enabling Analytics & System Excellence will oversee clinical systems and processes, enhancing organizational capabilities and optimizing processes to drive efficiency and quality across development initiatives.

Hospital & Health Care
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Leads the identification and implementation of technology solutions designed to optimize processes and deliver measurable value
Collaborates with clinical trial teams to assess their needs, exploring opportunities for innovation and continuous improvement through design thinking and agile methodologies
Work with study teams and partners on the study build, maintenance and use of supported systems during the lifecycle of a study
Provide end user support and expertise via support ticket intake, mailbox inquiries or other mechanisms
Serves as a point of contact for onboarding new organizations/acquisitions/divestitures related to study data/document transfer within scope of I&PS or CTM Solutions
Coordinate System release management activities including UAT testing and system improvements, and development/maintenance of system integrations including partnerships with IT and system owners
Troubleshoots advanced system issues, working with IT and external vendors to resolve challenges and ensure the continuous operation of supported capabilities
Create / update training materials and reference documentation to support end users, and present to user community groups to drive usage and compliant use of systems
Lead team meetings, manage projects and participate in cross-functional projects
Collaborate with Subject Matter Experts, Process Owners, and Functional Management to ensure alignment with timelines, organizational SOPs, and regulatory requirements
Responsible for development and monitoring of metrics dashboards
Lead audit / inspection activities, including CAPA management
Sponsor external resources and serve as mentor to more junior internal resources
May serve as Owner for CTM Solution or I&PS capabilities
Represent on organizational initiatives

Qualification

Clinical trial executionIT systems supportProject Management certificationClinical Practices (GCPs)FDA regulations knowledgeAnalytical ReasoningData SavvyDigital FluencyDigital StrategyProduct DesignProduct DevelopmentProduct ImprovementsProduct Portfolio ManagementReport WritingResearchDevelopmentSafety-OrientedSAP Product Lifecycle ManagementStatisticsTechnical CredibilityTechnologically SavvyCritical Thinking

Required

Minimum of a Bachelor's degree is required (preferably in Health, Science, Information Technology or another relevant field)
Minimum of 4-6 years of relevant experience in clinical trial execution with a Pharmaceutical, Medical Device company and/or a Clinical Research Organization (CRO)
Experience working with IT systems and related processes that support clinical development, reporting tools, Office 365 applications, and database administration
Knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations
The ability to partner with stakeholders and influence decision-making across a matrix organization
Excellent analytical, problem solving, communication and presentation skills
Global business mindset
Ability to travel up to 10% of the time (Domestic/International)

Preferred

Experience with direct support of IT systems and related processes that support clinical development
Project Management or Process Improvement certification
Demonstrated ability to translate the use of technology to be applied to solving business problems and/or to improve business outcomes

Benefits

Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year

Company

Johnson & Johnson

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At Johnson & Johnson, we believe health is everything.

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)

Funding

Current Stage
Late Stage

Leadership Team

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Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
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Joaquin Duato
Chairman of the Board and Chief Executive Officer
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Company data provided by crunchbase