Description

The Digital Health Technologies (DHT) Manager is accountable for the implementation of digital tools and technologies (e.g. electronic COA (eCOA), econsent, wearables, sensors, spirometry, ECG, etc.) in individual clinical research studies from study design to close out in collaboration with the study team. In this role, a typical day may include: Accountability for all supported digital tool and technology project timelines, training development, translation, specifications, executing UAT, and ensuring collection of such data is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight of digital technologies will vary accordingly. Responsible for enforcing digital tools and technology system standards, managing vendor performance, and supporting training & education of stakeholders. This position will participate in process improvement and strategy development initiatives in global development.

***Please note this role is an onsite position and is NOT eligible remote.

A typical day in this role looks like:

Responsible & accountable for the successful implementation of digital tools and technologies for one or more clinical research trials with quality and compliance
Applies patient technology expertise on day-to-day activities, cross-functional and departmental process improvements, supplier selection, and escalations.
Provides input into protocol development as it relates to digital tools and technologies
May participate in creation of digital tools and technology standards
Define and support study level strategy for the implementation, validation, and maintenance of various digital tools and technologies
Oversee or support license acquisitions and purchasing of digital tools and technologies
Oversee vendor performance at the clinical trial level, including oversight of KPI, performing root cause analysis and identifying corrective actions, and serving as point of escalation for supported translations, digital tools and technology issues.
Uses interpersonal, negotiating, and project management skills to perform the following tasks as related to digital tools and technologies project implementation:
- Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all supported technology systems related issues and end of study vendor deliverables
- Project documentation management
- Risk management planning
- Communication planning, information distribution, performance reporting, and project closure.
- Performing lessons learned
Monitor financial components related to digital tools and technologies for each study
Provides training and mentor new staff
Drive strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment
Support strategy for implementation of innovative clinical trial technologies and disruptive innovations for both stakeholders and the broader organization.
Provide consultation on digital tool modality benefits, risks, costs and process
May require up to 25% travel

This role may be for you if you have:

Demonstrate knowledge of some digital tools and technologies. Specifically, eCOA systems development processes
Demonstrated interpersonal & leadership skills
Ability to understand and implement the strategic direction and guidance for respective clinical studies
A data driven approach to planning, executing, and problem solving
Effective communication skills via verbal, written and presentation abilities
Ability independently perform and manage multiple tasks at one time and meet deadlines in a complex environment working both internal to Regeneron and external vendors
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
Ability to influence and negotiate
An awareness of relevant industry trends

In order to be considered qualified for the this role, a minimum of a Bachelors degree and 6+ years or relevant industry related experienced in required.

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 location. In 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. 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 Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s 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 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)

$114,800.00 - $187,400.00

Digital Health Technologies Manager

Description

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