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

The Senior Engineer, Enabling Analytics & System Excellence (Clinical Trial Management Solutions) will provide expertise in the planning, administration and oversight of clinical systems and related processes administered by EASE within Clinical Trial Management Solutions (CTM Solutions) or Investigator & Patient Solutions (I&PS). Provides support for capabilities related to clinical trial document management/TMF, study management and oversight. Provides support for capabilities related to patient engagement & recruitment, site staff enablement, clinical staff training and digital health enablement. Under general direction, this role executes plans and processes that innovate product development, meet organization standards, and follow digital strategy. This role is a liaison between the business community and key partners and stakeholders. Senior Engineer, Enabling Analytics & System Excellence (Clinical Trial Management Solutions) plays a pivotal role in enhancing organizational capabilities, optimizing processes, and fostering collaboration to drive strategy, efficiency and quality across J&J systems and development initiatives.

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

Minimum Education

Minimum of a Bachelor\’s degree is required (preferably in Health, Science, Information Technology or another relevant field)

Requirements

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