About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science‑based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
Purpose
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.
You will be responsible for
- Lead the identification and implementation of technology solutions designed to optimize processes and deliver measurable value.
- Collaborate 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.
- Serve 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 with IT and system owners.
- Troubleshoot advanced system issues with IT and external vendors to ensure continuous operation of supported capabilities.
- Create and 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.
- Develop and monitor metrics dashboards.
- Lead audit/inspection activities, including CAPA management.
- Serve as sponsor for external resources and mentor more junior internal resources.
- May serve as owner for CTM Solution or I&PS capabilities.
- Represent on organizational initiatives.
Qualifications / Requirements
Education
- Minimum of a Bachelor’s degree required (preferably in Health, Science, Information Technology or another relevant field).
Required Experience
- 4‑6 years of relevant experience in clinical trial execution with a Pharmaceutical, Medical Device company and/or a 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.
- 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
- 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 solve business problems and/or improve business outcomes.
Compensation and Benefits
The anticipated base pay range for this position is $109,000 to $174,800 (USD). Additional compensation and benefits information is available on the company website.
EEO Statement
Johnson & Johnson is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Job ID
Required Skills: Analytical Reasoning, Critical Thinking, Data Savvy, Digital Fluency, Digital Strategy, Engineering, Product Design, Product Development, Product Improvements, Product Portfolio Management, Report Writing, Research and Development, Safety‑Oriented, SAP Product Lifecycle Management, Statistics, Technical Credibility, Technologically Savvy.
Benefits
Employees may participate in medical, dental, vision, life insurance, short- and long-term disability, accident insurance, group legal insurance, pension and 401(k) plans. Time‑off benefits include vacation, sick time, holiday pay, floating holidays, and family time. For additional general information, visit https://www.careers.jnj.com/employee-benefits.