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.

***Please note this role is an onsite position and is NOT eligible remote.

A typical day in this role looks like:

• 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

This role may be for you if you have:

• 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
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Ability to influence and negotiate
• An awareness of relevant industry trends

In order to be considered qualified for the this role, a minimum of a Bachelors degree and 6+ years or relevant industry related experienced in required.