Principal Engineer, Investigator & Patient Solutions
About The Position
The Principal Engineer, Investigator & Patient Solutions (I&PS) is responsible for shaping the interfaces between partners, system and process for capabilities administered by EASE within Investigator & Patient Solutions (I&PS). The Principal Engineer within I&PS 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, Investigator & Patient Solutions (I&PS) 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.
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 6 years of relevant industry experience 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
- Ability to travel up to 10% of the time (Domestic/International) is required.
- Ability to communicate effectively in English.
- Global business mindset.
Nice To Haves
- Project Management or Process Improvement certification is preferred.
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 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 I&PS capabilities
- Represent on/lead organizational initiatives
Benefits
- employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
