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). This role supports capabilities related to clinical trial document management/TMF, study management, patient engagement & recruitment, site staff enablement, clinical staff training, and digital health enablement. Under general direction, the role executes plans that innovate product development, meet organization standards, and follow a digital strategy. The Senior Engineer serves as a liaison between the business community and key partners and stakeholders, enhancing organizational capabilities, optimizing processes, and fostering collaboration to drive strategy, efficiency, and quality across J&J systems.
Responsibilities
- Lead identification and implementation of technology solutions designed to optimize processes and deliver measurable value.
- Collaborate with clinical trial teams to assess needs, exploring opportunities for innovation and continuous improvement through design thinking and agile methodologies.
- Work with study teams and partners on the build, maintenance, and use of supported systems throughout the study lifecycle.
- Provide end‑user support and expertise via support ticket intake, mailbox inquiries, or other mechanisms.
- Serve as point of contact for onboarding new organizations, acquisitions, or divestitures related to study data/document transfer within the scope of I&PS or CTM Solutions.
- Coordinate system release‑management activities, including UAT testing, system improvements, and development/maintenance of system integrations in partnership with IT and system owners.
- Troubleshoot advanced system issues, working with IT and external vendors to resolve challenges and 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 align with timelines, organizational SOPs, and regulatory requirements.
- Develop and monitor metrics dashboards.
- Lead audit/inspection activities, including CAPA management.
- Sponsor external resources and mentor junior internal resources.
- May serve as owner for CTM Solution or I&PS capabilities.
- Represent on organizational initiatives.
- Minimum of a Bachelor’s degree (preferably in Health, Science, Information Technology, or a related field).
Required Qualifications
- 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 supporting clinical development (reporting tools, Office 365, 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 Qualifications
- Experience with direct support of IT systems and related processes that support clinical development.
- Project Management or Process Improvement certification.
- Demonstrated ability to translate technology use to solve business problems and/or improve business outcomes.
Compensation & Benefits
The anticipated base pay range for this position is $109,000 to $174,800 (USD). The Company maintains competitive, performance‑based compensation programs and eligibility for an annual performance bonus.
Employees may be eligible to participate in the following benefit programs:
- Medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance.
- Consolidated retirement plan (pension) and savings plan (401(k)).
- Vacation – up to 120 hours per calendar year.
- Sick time – up to 40 hours per calendar year; for employees residing in Washington state – 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.