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

Johnson & Johnson Innovative Medicine • Horsham, PA

1d • Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Senior Engineer, Enabling Analytics & System Excellence (Clinical Trial Management Solutions) to be located in High Wycombe, United Kingdom, Beerse, Belgium or Horsham, United States (Hybrid). Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): High Wycombe, UK - Requisition Number: R-038119 Beerse, Belgium - Requisition Number: R-040096 Horsham, United States – Requisition Number: R-046904 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. 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. 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.

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)

Nice To Haves

• 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

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

Benefits

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits: - 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
• The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees