Manager, Digital Health Technologies

Responsibilities:
- Accountable for implementation of digital tools and technologies (e.g., eCOA, eConsent, wearables, sensors, spirometry, ECG) across one or more clinical research trials from study design to closeout.
- Ensure timelines, training development, translation, specifications, and execution of UAT; ensure data collection complies with SOPs and ICH/GCP.
- Enforce digital tools/technology system standards; manage vendor performance and serve as escalation point for digital tool/technology issues.
- Provide patient technology expertise for cross-functional/process improvements, supplier selection, and escalations.
- Provide input into protocol development related to digital tools/technologies; participate in creating digital tool/technology standards.
- Define and support study-level strategy for implementation, validation, and maintenance of digital tools/technologies.
- Oversee/support license acquisitions and purchasing.
- Oversee vendor performance, including KPI oversight, root cause analysis, corrective actions, and oversight of end-of-study vendor deliverables.
- Lead project plan development/execution and change control; coordinate resolution and risk mitigation.
- Manage project documentation; perform risk management planning; execute communication planning, information distribution, performance reporting, and project closure.
- Conduct lessons learned activities.
- Monitor financial components related to digital tools/technologies.
- Provide training and mentor new staff.
- Drive strategy for expanding eSource modalities for virtual clinical trials.
- Support implementation strategy for innovative/disruptive clinical trial technologies.
- Consult on benefits, risks, costs, and processes for digital tool modalities.
- May require up to 25% travel.

Qualifications:
- Bachelor’s degree.
- Minimum 5 years relevant industry experience.
- Demonstrated knowledge of digital tools/technologies, specifically eCOA systems development processes.
- Demonstrated interpersonal and leadership skills.
- Ability to understand and implement strategic direction for clinical studies.

Required/Preferred Skills:
- Data-driven approach to planning, executing, and problem-solving.
- Effective verbal, written, and presentation communication.
- Ability to manage multiple tasks independently and meet deadlines in a complex environment with internal teams 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, cross-functional leadership, and organizational skills.

Benefits:
- In the U.S., benefits may include 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).

Application Instructions:
- “Apply now to take your first step towards living the Regeneron Way!”