Manager Digital Health Technologies

Full job description

The Digital Health Technologies (DHT) Manager is accountable for electronic COA (eCOA) in individual clinical research studies from study design to close out in collaboration with the study team. In this role, a typical day might include: Accountability for the eCOA project timelines, translation, eCOA study specifications, executing UAT, and ensuring collection of eCOA is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight of eCOA will vary accordingly. Responsible for creating and enforcing eCOA systems standards, managing vendor performance, and supporting training & education of stakeholders. May participate in process improvement initiatives in global development.

In this role, a typical day might include being:
Responsible & accountable for the successful delivery of eCOA for one or more clinical research trials with quality and compliance

Responsible for reviewing and approving project related eCOA study documentation during the course of the Project Lifecycle

Applies eCOA systems expertise on day-to-day activities when issues are escalated

Communicates with internal and external stakeholders and escalates risks

Provides input into protocol development as it relates to clinical outcomes

This role might be for you if can:
Provides support for problem resolution between eCOA vendors and Regeneron study team

Monitor financial components related to COA and Innovation for each study

Collaborate with study team members on medical monitoring plan

Collaborate with data management on eCOA data specifications, standards, and transfers

Provides training and mentors new staff

Apply problem solving strategies to issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations
To be considered for this opportunity, we expect candidates to have at least 5 years of relevant experience within the eCOA field and have foundational knowledge of clinical studies.
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Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually) $108,200.00 - $176,600.00