Manager, Digital Health Technologies

Regeneron Pharmaceuticals • Warren, MI

20h • Onsite

About The Position

The Digital Health Technologies (DHT) Manager is accountable for the implementation of digital tools and technologies (e.g. electronic COA (eCOA), eConsent, wearables, sensors, spirometry, ECG, etc.) in individual clinical research studies from study design to close out in collaboration with the study team. In this role, a typical day may include: Accountability for all supported digital tool and technology project timelines, training development, translation, specifications, executing UAT, and ensuring collection of such data is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight of digital technologies will vary accordingly. Responsible for enforcing digital tools and technology system standards, managing vendor performance, and supporting training & education of stakeholders. This position will participate in process improvement and strategy development initiatives in global development. A typical day may include the following: Responsible & accountable for the successful implementation of digital tools and technologies for one or more clinical research trials with quality and compliance Applies patient technology expertise on day-to-day activities, cross-functional and departmental process improvements, supplier selection, and escalations. Provides input into protocol development as it relates to digital tools and technologies May participate in creation of digital tools and technology standards Define and support study level strategy for the implementation, validation, and maintenance of various digital tools and technologies Oversee or support license acquisitions and purchasing of digital tools and technologies Oversee vendor performance at the clinical trial level, including oversight of KPI, performing root cause analysis and identifying corrective actions, and serving as point of escalation for supported translations, digital tools and technology issues. Uses interpersonal, negotiating, and project management skills to perform the following tasks as related to digital tools and technologies project implementation: Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all supported technology systems related issues and end of study vendor deliverables Project documentation management Risk management planning Communication planning, information distribution, performance reporting, and project closure. Performing lessons learned Monitor financial components related to digital tools and technologies for each study Provides training and mentor new staff Drive strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment Support strategy for implementation of innovative clinical trial technologies and disruptive innovations for both stakeholders and the broader organization. Provide consultation on digital tool modality benefits, risks, costs and process May require up to 25% travel

Requirements

• Bachelor’s degree and minimum of 5 years relevant industry experience including a demonstrate knowledge of some digital tools and technologies, Specifically eCOA systems development processes
• Demonstrated interpersonal & leadership skills
• Ability to understand and implement the strategic direction and guidance for respective clinical studies
• A data driven approach to planning, executing, and problem solving.
• Effective communication skills via verbal, written and presentation abilities.
• Ability independently perform and manage multiple tasks at one time and meet deadlines in a complex environment working both internal to Regeneron and external vendors.
• Demonstrated vendor management experience.
• Technical proficiency in trial management systems and Microsoft Project Server
• Knowledge of ICH/GCP and regulatory guidelines/directives.
• Effective project management skills, cross-functional team leadership and organizational skills

Responsibilities

• Accountability for all supported digital tool and technology project timelines, training development, translation, specifications, executing UAT, and ensuring collection of such data is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.
• Responsible for enforcing digital tools and technology system standards, managing vendor performance, and supporting training & education of stakeholders.
• Responsible & accountable for the successful implementation of digital tools and technologies for one or more clinical research trials with quality and compliance
• Applies patient technology expertise on day-to-day activities, cross-functional and departmental process improvements, supplier selection, and escalations.
• Provides input into protocol development as it relates to digital tools and technologies
• Define and support study level strategy for the implementation, validation, and maintenance of various digital tools and technologies
• Oversee or support license acquisitions and purchasing of digital tools and technologies
• Oversee vendor performance at the clinical trial level, including oversight of KPI, performing root cause analysis and identifying corrective actions, and serving as point of escalation for supported translations, digital tools and technology issues.
• Uses interpersonal, negotiating, and project management skills to perform the following tasks as related to digital tools and technologies project implementation: Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all supported technology systems related issues and end of study vendor deliverables Project documentation management Risk management planning Communication planning, information distribution, performance reporting, and project closure. Performing lessons learned
• Monitor financial components related to digital tools and technologies for each study
• Provides training and mentor new staff
• Drive strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment
• Support strategy for implementation of innovative clinical trial technologies and disruptive innovations for both stakeholders and the broader organization.
• Provide consultation on digital tool modality benefits, risks, costs and process

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

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