Principal Engineer Digital Health Enablement

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 comJob Function R D Product DevelopmentJob Sub Function R D DigitalJob Category Scientific TechnologyAll Job Posting Locations Bangalore Karnataka India Hyderabad Andhra Pradesh India Mumbai Maharashtra India 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 bachelors degree or equivalent is required preferably in Health Science Information Technology or another relevant field A minimum of 6 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