Senior Manager, Clinical Outcomes Assessment

Warren, OH - USA

Monthly Salary: $ 134400 - 219200

Posted on: 15 hours ago

Vacancies: 1 Vacancy

Job Summary

As a Senior Manager Digital Health Technologies (DHT) you will be accountable for implementation of digital tools and technologies (e.g. electronic COA (eCOA) eConsent wearables sensors spirometry ECG) in individual clinical research studies from study design to close out. We support digital tool and technology project timelines translation specifications implementing UAT and ensuring collection of such data in accordance with our SOPs and ICH/GCP. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs).

This position is on-site either in Sleepy Hollow NY or Warren NJ locations. If eligible we can offer relocation assistance. We cannot offer a remote work option.

A typical day may include the following:
Responsible for reviewing and approving various project related digital tool and technology study documentation during the course of the project lifecycle.
Applies patient technology expertise on day-to-day activities when issues are brought up.
Communicates with internal and external partners and raises risks.
Provides input into protocol development as it relates to digital tools and technologies.
Support the integration of all supported digital tools and technologies into existing systems and workflows to minimize disruption and improve efficiency.
Oversee or supports license acquisitions and purchasing of digital tools and technologies.
Responsible for the selection of the digital tool and technology vendor selection in collaboration with study team.
Oversee vendor performance at the clinical trial level performing root cause analysis and identifying corrective actions and serving as point of escalation for issues.
Project plan development execution and change control. Coordinates resolution & risk mitigation of all supported technology systems related issues and end of study vendor deliverables
Provides support for problem resolution between vendors and Regeneron study team.
Monitor financial components related to digital tools and technologies for each study.
Collaborate with study team members on medical monitoring plan.
Collaborate with data management on all digital tool data specifications standards and transfers.
Provides training and mentor new staff.
Apply problem solving strategies to issues and maintain issue tracking documentation to monitor progress and ensure timely resolution to escalations.
Develop strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment.
Communicates clinical innovations in eSource modalities to stakeholders and broader organization.
Develop trial strategy for implementation of innovative clinical trial technologies and radical innovations.
Provide consultation on all digital tool modality benefits risks costs and process.
Facilitates and contributes to study level lessons learned.
Recommends and participates in cross-functional and departmental process improvement initiatives.
May require up to 25% travel.

This may be for you if you:
Want to have an impact on patient lives.
Have a data driven approach to planning executing and problem solving
Can demonstrate effective project management skills cross-functional team leadership and organizational skills.

To be considered you are to have a bachelors degree and minimum of 8 years relevant industry experience. Demonstrate knowledge of digital tools and technologies within the eCOA systems development processes. Ability to understand and implement our strategic direction and guidance for respective clinical studies. Technical proficiency in trial management systems and Microsoft Project Server. Knowledge of ICH/GCP and regulatory guidelines/directives

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits which vary by the U.S. benefits may include health and wellness programs (including medical dental vision life and disability insurance) fitness centers 401(k) company match family support benefits equity awards annual bonuses paid time off and paid leaves (e.g. military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US please visit For other countries specific benefits please speak to your recruiter.
Please be advised that at Regeneron we believe we are most successful and work best when we are together. For that reason many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location.

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 Companys 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)

$134400.00 - $219200.00

Required Experience:

Senior Manager

This position is on-site either in Sleepy Hollow NY or Warren NJ locations. If eligible we can offer relocation assistance. We cannot offer a remote work option.