Senior Manager, Digital Health Technologies (eCOA)
Regeneron
9 hours ago
On-site
Warren, NJ
IT
Senior Manager, Digital Health Technologies (DHT) responsible for implementing digital tools and technologies (e.g., eCOA, eConsent, wearables, sensors, spirometry, ECG) in clinical research studies from study design through close-out. Supports digital tool/technology project timelines, translation, specifications, UAT, and ensures data collection in accordance with SOPs and ICH/GCP. Applies to internally sourced and CRO- outsourced studies.
Responsibilities:
- Review and approve project-related digital tool/technology study documentation across the project lifecycle.
- Apply patient technology expertise to resolve day-to-day technology issues.
- Communicate with internal/external partners and raise risks.
- Provide input into protocol development related to digital tools/technologies.
- Support integration of digital tools/technologies into existing systems and workflows to minimize disruption and improve efficiency.
- Oversee and/or support license acquisitions and purchasing of digital tools/technologies.
- Select digital tool/technology vendors in collaboration with the study team.
- Oversee vendor performance at the clinical trial level; conduct root cause analysis, define corrective actions, and serve as escalation point.
- Develop/execute project plans and change control; coordinate resolution and risk mitigation for technology issues and end-of-study vendor deliverables.
- Support problem resolution between vendors and the study team.
- Monitor study financial components related to digital tools/technologies.
- Collaborate with study team on medical monitoring plan.
- Collaborate with data management on digital tool data specifications, standards, and transfers.
- Provide training and mentor new staff.
- Use problem-solving and maintain issue tracking to ensure timely escalation resolution.
- Develop strategy/processes to expand eSource modalities for virtual clinical trial data availability.
- Communicate eSource modality innovations to stakeholders.
- Develop trial strategy for innovative and radical clinical trial technologies.
- Consult on benefits, risks, costs, and processes for digital tool modalities.
- Facilitate and contribute to study-level lessons learned.
- Recommend and participate in cross-functional/departmental process improvement initiatives.
- May require up to 25% travel.
Qualifications:
- Bachelor’s degree.
- Minimum 8+ years of relevant industry experience.
Required/Preferred Skills:
- Knowledge of digital tools/technologies within eCOA systems development processes.
- Ability to understand and implement strategic direction for respective clinical studies.
- Technical proficiency in trial management systems and Microsoft Project Server.
- Knowledge of ICH/GCP and regulatory guidelines/directives.
Benefits:
- Health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees in the U.S.
Application Instructions:
- Apply now to take your first step towards living the Regeneron Way.
Responsibilities:
- Review and approve project-related digital tool/technology study documentation across the project lifecycle.
- Apply patient technology expertise to resolve day-to-day technology issues.
- Communicate with internal/external partners and raise risks.
- Provide input into protocol development related to digital tools/technologies.
- Support integration of digital tools/technologies into existing systems and workflows to minimize disruption and improve efficiency.
- Oversee and/or support license acquisitions and purchasing of digital tools/technologies.
- Select digital tool/technology vendors in collaboration with the study team.
- Oversee vendor performance at the clinical trial level; conduct root cause analysis, define corrective actions, and serve as escalation point.
- Develop/execute project plans and change control; coordinate resolution and risk mitigation for technology issues and end-of-study vendor deliverables.
- Support problem resolution between vendors and the study team.
- Monitor study financial components related to digital tools/technologies.
- Collaborate with study team on medical monitoring plan.
- Collaborate with data management on digital tool data specifications, standards, and transfers.
- Provide training and mentor new staff.
- Use problem-solving and maintain issue tracking to ensure timely escalation resolution.
- Develop strategy/processes to expand eSource modalities for virtual clinical trial data availability.
- Communicate eSource modality innovations to stakeholders.
- Develop trial strategy for innovative and radical clinical trial technologies.
- Consult on benefits, risks, costs, and processes for digital tool modalities.
- Facilitate and contribute to study-level lessons learned.
- Recommend and participate in cross-functional/departmental process improvement initiatives.
- May require up to 25% travel.
Qualifications:
- Bachelor’s degree.
- Minimum 8+ years of relevant industry experience.
Required/Preferred Skills:
- Knowledge of digital tools/technologies within eCOA systems development processes.
- Ability to understand and implement strategic direction for respective clinical studies.
- Technical proficiency in trial management systems and Microsoft Project Server.
- Knowledge of ICH/GCP and regulatory guidelines/directives.
Benefits:
- Health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees in the U.S.
Application Instructions:
- Apply now to take your first step towards living the Regeneron Way.