Regeneron · 4 hours ago
Senior Manager Clinical Study Lead (Diabetes/Obesity/Metabolism)
Armonk, NY
Full-time
Onsite
Senior Level, Lead/Staff
$148K/yr - $242K/yr
8+ years expRegeneron is a leading biotechnology company focused on developing innovative medicines. The Senior Clinical Study Lead is responsible for the global execution of complex clinical trials, ensuring compliance with standards and managing study timelines and budgets.
BiopharmaBiotechnologyPharmaceutical
Responsibilities
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
Provides operational input into protocol development
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
Ensures compliance with the clinical trial registry requirements
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
Oversees/conducts site evaluation and selection
Leads investigator meeting preparation and execution
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
Ensures accurate budget management and scope changes for internal and external studies
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
Oversees the execution of the clinical study against planned timelines, deliverables and budget
Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
Ensure clinical project audit and inspection readiness through the study lifecycle
Supports internal audit and external inspection activities and contributes to CAPAs as required
Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
Contributes to clinical study report writing and review
Facilitates and contributes to study level lessons learned
Assigns tasks to Clinical Study Management staff and supports their deliverables
Recommends and participates in cross-functional and departmental process improvement initiatives
Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs
May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring
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
May require 25% travel
Qualification
Required
A minimum of a Bachelor's degree is required
A minimum of 8 years relevant clinical trial experience at sponsor, CRO, site
Exceptional interpersonal & leadership skills
Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies
Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving
Advanced 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
Strong budget management experience
An awareness of relevant industry trends
Ability to build, lead and develop productive study teams and collaborations
Applies advanced negotiation and interpersonal skills to vendor management
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
Knowledge of ICH/GCP and regulatory guidelines/directives
Advanced project management skills, cross-functional team leadership and organizational skills
Line management experience
Prior experience in Obesity/Metabolism/Diabetes related trials related
Extensive Phase III experience needed
Benefits
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)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
Pharmaceutical Technology
2025-12-29
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