Johnson & Johnson - Principal Engineer Digital Health Enablement Role (8-16 yrs)

Integrated Data Analytics and Reporting (IDAR)

Principal Engineer Digital Health Enablement-

(-Title may vary based on Region or Country requirements)

Position Summary:

The Principal Engineer Digital Health Enablement is responsible for shaping the interfaces between partners, system and process for capabilities administered by Enabling Analytics & System Excellence EASE within Clinical Trial Management Solutions (CTM Solutions) or Investigator & Patient Solutions (I&PS).

- The Principal Engineer Digital Health Enablement within CTM Solutions will oversee end to end system planning, administration, oversight and related processes for capabilities supporting clinical trial document management/TMF, study management and oversight.

- The Principal Engineer Digital Health Enablement will oversee end to end system planning, administration, oversight and related processes for capabilities supporting patient engagement, site staff enablement, clinical staff training.

This includes driving customer enablement and innovative solutions for the supported capabilities: collaborating across Product Groups and including business partners, IT and suppliers, metrics oversight, user administration and support, system integrations management, continuous improvement and change management.

The Principal Engineer Digital Health Enablement delivers operational results and assists with development of digital initiatives that innovate product development, meet organization standards, and drive digital strategy. Provides leadership, management, and/or coaching to a multidimensional R&D organization to ensure workforce effectiveness of the overall operations of the business.

Principal Responsibilities:

- Lead the identification and implementation of technology solutions designed to optimize processes and deliver measurable value.

- Lead continuous improvement initiatives, identifying new tools, processes, or technologies that enhance study team, patient and site engagement strategies.

- Troubleshoot system-wide issues, serving as a point of escalation for technical challenges that impact CTM Solutions and/or or I&PS activities.

- Ensure robust project management practices, including developing business cases, project plans, and financial oversight, are applied to solution delivery.

- Partner with IT and vendors to ensure strong system change control strategies, minimizing disruption and aligning updates with best practices.

- Manage financial planning and budgets, ensuring efficient allocation of resources for technology implementation and continuous improvement.

- Lead a high-functioning and diverse team to enable industry-leading inspection-ready practices for the supported capabilities, with a focus on delivering measurable value for stakeholders.

- Lead change management efforts, promoting the adoption of new tools and ensuring clinical trial teams are well-equipped to use them effectively.

- Remaining connected as a primary point of contact with stakeholders, functional area points of contact and subject matter expert frameworks.

- Provide ongoing training and support, ensuring clinical study teams have the resources they need to maximize tools and processes.

- Engage in System/Process audits and Sponsor Inspections as a subject matter expert for supported capabilities.

- Lead and/or contribute to cross-functional strategic projects

- Train and mentor colleagues.

- Serve as Owner for CTM Solutions or I&PS capabilities

- Represent on/lead organizational initiatives

Principal Relationships:

- Internal: Global Development Departments and Leadership; IT; R&D Quality; MedTech; J&J Legal, J&J Finance

- External: System Vendors; Investigator Site Staff; CRO points of contact and resources; Regulatory Inspectors; Industry Peer Networks

Education and Experience Requirements:

- A minimum of a bachelor's degree or equivalent is required, preferably in Health, Science, Information Technology or another relevant field.

- A minimum of 8-10+ years of relevant experience in clinical trial execution with a Pharmaceutical, Medical Device company and/or a Clinical Research Organization (CRO) is required.

- Proficiency supporting IT systems and related processes that support clinical development, reporting tools, Office 365 applications, and database administration is required.

- Solid understanding of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.

- The ability to partner and influence people at all levels of the organization is required.

- Superior communication, business partnering, problem solving, and prioritization skills are required

- Project Management or Process Improvement certification is preferred.

Other:

- Ability to travel up to 10% of the time (Domestic/International) is required.

- Ability to communicate effectively in English.

- Global business mindset.