Senior Manager, Global Study Start Up

Regeneron

Senior Manager responsible for global site start-up and activation at Regeneron. Leading site management activities while ensuring regulatory compliance and efficient processes.

Posted 5/29/2026full-timeWarren • New York • 🇺🇸 United StatesSenior💰 $134,400 - $219,200 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Develop the site start up strategy for each assigned study
Oversee the tracking and analysis of study metrics
Advocate for optimized site selection strategies
Lead the development, assessment, and alignment of site activation projections
Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF)
Partner with cross functional and CRO partners to develop global country start up strategy
Monitor and maintain country intelligence data
Support regulatory submissions as needed
Ensure timely country submission deliverables
Lead and oversee all aspects of site start-up activities
Serve as the subject matter expert for essential site documents
Oversee CRO site start up management or in house site facing regional SSU team
Represent SSU on cross-functional teams
Recommends and drives cross functional and department process improvements
Responsible for direct supervision of SSU staff

Requirements

What you’ll need

Minimum of a Bachelor's degree
8+ years of relevant industry experience
Strong interpersonal and leadership skills
Ability to provide and implement operational strategic direction and guidance for respective clinical trials
Demonstrates strong knowledge and a data-driven approach to planning, executing, and problem-solving
Strong communication skills via verbal, written and presentation abilities
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
Ability to influence and negotiate across a wide range of stakeholders
Ability to lead and develop productive study teams and collaborations
Applies advanced negotiation and interpersonal skills to vendor management
Strong technical proficiency in trial management systems (CTMS, TMF) and MS applications (Project, PowerPoint, Word, Excel)
Extensive experience in the clinical drug development process, including study start-up
Knowledge and understanding of ICH/GCP and regulatory guidelines/directives
Strong project management skills, cross-functional team interaction and organizational skills
Line management experience preferred

Benefits

Comp & perks

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
paid leaves (e.g., military and parental leave) for eligible employees at all levels!

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial managementsite start-up strategydata analysisproject managementregulatory submissionsvendor managementproblem-solvingplanningexecutionnegotiation

Soft Skills

interpersonal skillsleadership skillscommunication skillstime managementprioritizationinfluencecollaborationself-disciplineteam developmentprocess improvement