Manager Digital Health Technologies

3 months ago

Dublin, Ireland Regeneron Pharmaceuticals, Inc Full time

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 6+ years of relevant experience within the eCOA field and have foundational knowledge of clinical studies.

#GDDOPMJobs #LI-Hybrid

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