Senior Engineer, Enabling Analytics – System Excellence
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: High Wycombe • Virginia • United States
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Salary
💰 $109,000 - $174,800 per year
Job Level
About the role
- 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
Requirements
- 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)
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; up to 56 hours per calendar year for employees in the State of Washington.
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial executionsystem integrationsUAT testingmetrics dashboardsCAPA managementdatabase administrationdesign thinkingagile methodologiesproblem solvinganalytical skills
Soft Skills
communication skillspresentation skillsstakeholder partnershipinfluence decision-makingteam leadershipproject managementcollaborationmentoringorganizational skillsglobal business mindset
Certifications
Bachelor’s degreeGood Clinical Practices (GCPs)