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Location:
null, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
897a2a0a411b
Job Views:
130
Posted:
03.03.2025
Expiry Date:
17.04.2025
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:
1. 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.
2. Responsible for creating and enforcing eCOA systems standards, managing vendor performance, and supporting training & education of stakeholders.
3. May participate in process improvement initiatives in global development.
In this role, a typical day might include being:
1. Responsible & accountable for the successful delivery of eCOA for one or more clinical research trials with quality and compliance.
2. Responsible for reviewing and approving project related eCOA study documentation during the course of the Project Lifecycle.
3. Applies eCOA systems expertise on day-to-day activities when issues are escalated.
4. Communicates with internal and external stakeholders and escalates risks.
5. Provides input into protocol development as it relates to clinical outcomes.
This role might be for you if you can:
1. Provide support for problem resolution between eCOA vendors and Regeneron study team.
2. Monitor financial components related to COA and Innovation for each study.
3. Collaborate with study team members on medical monitoring plan.
4. Collaborate with data management on eCOA data specifications, standards, and transfers.
5. Provide training and mentor new staff.
6. 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.
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