Manager Clinical Outcomes Assessment

The Clinical Outcomes Assessment Manager is accountable for electronic COA (eCOA) in individual clinical research studies from study design to close out in collaboration with the study team. To lead eCOA project timelines, translation, eCOA study specifications,  completing 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, handling vendor performance, and supporting training & education of partners. May participate in process improvement initiatives (including onboarding of Digital Health Technologies) in global development.

Job Duties:

• 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 raised

• Communicates with internal and external stakeholders and escalates risks

• Provides input into protocol development as it relates to clinical outcomes

• May participate in creation of eCOA standards

• Define and support strategy for eCOA migration and COA validation

• Support COA Specialists with license acquisition

• Responsible for eCOA and translation vendor selection, in collaboration with study team

• Oversee eCOA 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 eCOA issues.

• Uses interpersonal, negotiating, and project management skills to perform the following tasks as related to COA:

• Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all eCOA systems related issues and end of study vendor deliverables

• Risk management planning

• Communication planning, information distribution, performance reporting, and project closure.

• 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

• Develop strategy & processes for expansion of eSource modalities to enable data availability in a virtual clinical trial environment

• Facilitates in communication of clinical innovations in eSource modalities to customers and broader organization

• Support strategy for implementation of innovative clinical trial technologies and exciting innovations

• Provide consultation on eCOA 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

Job Requirements:

• Demonstrate knowledge of 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

• Demonstrated vendor management experience

• Technical proficiency in trial management systems and Microsoft Project Server

• Knowledge of ICH/GCP and regulatory guidelines/directives

• Effective project management skills, cross-functional team leadership and organizational skills

• Bachelor’s degree and minimum of 5 years relevant industry experience. 

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$108,200.00 - $176,600.00