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-HybridDoes this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.Salary Range (annually)$108,200.00 - $176,600.00