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Regeneron

Manager, Clinical Study Lead

Regeneron

Manager, Clinical Study Lead at Regeneron overseeing global clinical trials execution and cross-functional study teams in compliance with industry regulations.

Posted 5/5/2026full-timeWarren • New York • 🇺🇸 United StatesSenior💰 $128,600 - $210,000 per yearWebsite

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out
  • ensures study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP
  • leads the cross-functional study team responsible for clinical study delivery
  • oversees execution against planned timelines, deliverables, and budget while escalating issues to the Program Operations Lead
  • provides operational input into protocol development
  • oversees or conducts site evaluation and selection
  • leads investigator meeting preparation and execution
  • manages study close-out activities, including database lock, reconciliation of vendor contracts, and budget

Requirements

What you’ll need
  • Bachelor’s degree
  • at least six years of relevant industry experience
  • extensive budget management expertise
  • proven ability to build productive study teams and collaborations
  • demonstrated vendor management experience
  • strong technical proficiency with trial management systems and Microsoft applications (Project, PowerPoint, Word, Excel)
  • experience in global clinical trial operations, including developing protocols and key study documents
  • solid knowledge of ICH/GCP and relevant regulatory guidelines and directives
  • effective project management, cross-functional team leadership, and organizational skills

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)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
budget managementtrial management systemsprotocol developmentstudy document developmentdatabase lockvendor managementclinical trial executionstudy close-out activitiesregulatory guidelinesICH/GCP
Soft Skills
project managementcross-functional team leadershiporganizational skillscollaborationproblem-solvingcommunicationteam buildingstakeholder managementissue escalationoperational input