Senior Manager, Clinical Study Lead

Regeneron

Senior Clinical Study Lead overseeing complex clinical trials at Regeneron. Responsible for cross-functional study delivery and management of clinical study teams with significant industry experience.

Posted 5/27/2026full-timeArmonk • New Jersey, New York • 🇺🇸 United StatesSenior💰 $150,500 - $245,500 per yearWebsite

About the role

Key responsibilities & impact

Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
Provides input into baseline budget development and management
Provides input into baseline timeline development and management
Leads risk assessment and identifies risk mitigation strategies at the study level
Leads the feasibility assessment to select relevant regions and countries for the study
Monitors progress for site activation and monitoring visits and acts on any deviations from plan
Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
Monitors data entry and query resolution and acts on any deviations from agreed metrics
Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues
Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
May be assigned unmasked tasks for studies
Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight

Requirements

What you’ll need

A minimum of a Bachelor's degree is required
a minimum of 8 years relevant clinical trial experience
experience with line management
exceptional interpersonal and leadership skills
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
advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents
applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies

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

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial managementdata managementrisk assessmentbudget managementtimeline managementpatient recruitment strategiesdata entryquery resolutiondrug accountabilitystudy close-out activities

Soft Skills

interpersonal skillsleadership skillsproactiveself-disciplinedtime managementprioritizationinfluencenegotiationcoachingmentoring