Manager Clinical Study Lead

Regeneron Pharmaceuticals, Inc (USA); Armonk (NY); On-site; USD 128,600 - 210,000; Full time

Benefits offered by this job

Health and wellness programs

401(k) company match

Annual bonuses

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc (USA) in Armonk, NY is looking for a Manager, Clinical Study Lead to oversee the execution of clinical trials. This role includes managing timelines, budgets, and quality adherence while leading cross-functional teams.

The ideal candidate should have a Bachelor's degree and extensive experience in clinical trial operations, budget management, and strong technical proficiency with trial management tools.

Benefits include health programs, 401(k) match, equity awards, and annual bonuses.

Qualifications

• Bachelor’s degree and at least six years of relevant industry experience.
• Proven ability to build productive study teams and collaborations.
• Demonstrated vendor management experience.
• Strong technical proficiency with trial management systems.

Responsibilities

• Accountable for the global execution of assigned clinical trials.
• Lead the cross‑functional study team responsible for clinical study delivery.
• Manage study timelines and budgets, ensuring compliance with SOPs.
• Oversee and contribute to study documentation and systems.

Skills

Budget management expertise

Technical proficiency with trial management systems

Project management skills

Cross-functional team leadership

Education

Bachelor’s degree

Tools

Microsoft Project

Microsoft PowerPoint

Microsoft Word

Microsoft Excel

Job description

Overview

Build our future together: The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight.

Responsibilities

• Accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out.
• Accountable for the study timelines and budget and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.
• Lead the cross‑functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight, and oversee execution against planned timelines, deliverables, and budget while raising issues (conduct, quality, timelines, budget) to the Program Operations Lead and stakeholders and implementing corrective actions.
• Provide operational input into protocol development; lead feasibility assessments to select relevant regions and countries; oversee or conduct site evaluation and selection; and lead investigator meeting preparation and execution.
• Oversee and contribute to study documentation, including case report forms, data management plan, monitoring plan, monitoring oversight plan, project‑specific training plan, data review plan, statistical analysis plan, and related materials.
• Oversee set‑up and maintenance of study systems (e.g., CTMS, TMF) and ensure compliance with clinical trial registry requirements.
• Identify outsourcing needs and lead vendor engagement, contracting, and management; ensure CROs and third‑party vendors are aligned and delivering per scope of work.
• Provide input into baseline budget and timeline development and management; ensure accurate budget management and scope change control for internal and external studies.
• Lead study‑level risk assessment and mitigation; monitor site activation and monitoring visits and act on deviations; lead development and oversee implementation of patient recruitment and retention strategies and respond to deviations from plan; and monitor data entry and query resolution against agreed metrics.
• Manage study close‑out activities, including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability; contribute to clinical study report writing and review; and facilitate study‑level lessons learned.
• Assign tasks to Clinical Study Management staff and support their deliverables; directly supervise CTM staff (work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight); recommend and participate in cross‑functional and departmental process improvements; and identify innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs.
• May be assigned unmasked tasks for studies, which may include but are 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.

Qualifications

• Bachelor’s degree and at least six years of relevant industry experience.
• Extensive budget management expertise; proven ability to build productive study teams and collaborations; and demonstrated vendor management experience.
• Strong technical proficiency with trial management systems and Microsoft applications is required, including Project, PowerPoint, Word, Excel, and platforms such as IVRS/IWRS and EDC.
• Experience in global clinical trial operations, including developing protocols and key study documents; solid knowledge of ICH/GCP and relevant regulatory guidelines and directives; and effective project management, cross‑functional team leadership, and organizational skills.
• Ability to understand and implement the operational strategic direction and guidance for respective clinical studies.

Benefits

Regeneron offers a comprehensive benefits package. In the U.S., benefits may include 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, and paid leaves for eligible employees at all levels.

Work Location & Travel

Work locations: Armonk, NY; Warren, NJ; Uxbridge, UK. Hybrid: 4 days per week on site. 25% travel may be required.

Salary Range

Annually: $128,600.00 - $210,000.00.

Equal Opportunity Employer

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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.