Manager, Clinical Study Lead

Regeneron; New Jersey; Hybrid; USD 128,600 - 210,000; Full time

Benefits offered by this job

Annual bonuses

401(k) company match

Health and wellness programs

Job summary

Regeneron is seeking a Manager, Clinical Study Lead responsible for overseeing clinical trial execution and ensuring compliance with SOPs and ICH/GCP. The role involves leading cross-functional teams, managing study documentation, and ensuring the study budget is adhered to. Candidates should possess a Bachelor’s degree and at least six years of relevant experience.

Located in the United States, this hybrid role may require 25% travel. The compensation ranges from $128,600 to $210,000, along with a comprehensive benefits package.

Qualifications

• At least six years of relevant industry experience.
• Experience in global clinical trial operations.
• Solid knowledge of ICH/GCP and relevant regulatory guidelines.

Responsibilities

• Lead the cross-functional study team for clinical study delivery.
• Oversee and contribute to study documentation and compliance.
• Manage study close-out activities and contribute to clinical study reports.

Skills

Budget management expertise

Cross-functional team leadership

Technical proficiency with trial management systems

Microsoft applications (Project, PowerPoint, Word, Excel)

Education

Bachelor’s degree

Tools

IVRS/IWRS

EDC

Job description

Manager, Clinical Study Lead

The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials, including Phase IV/Real World Evidence studies, from study design, through execution, to study close out. You are accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives.

Location & Travel

• Work Location: Armonk, NY, Warren, NJ
• Hybrid; 4 days per week on site
• 25% Travel may be required

Key Responsibilities

• Leads the cross‑functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight, and oversees 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
• Provides operational input into protocol development; leads feasibility assessments to select relevant regions and countries; oversees or conducts site evaluation and selection; and leads investigator meeting preparation and execution
• Oversees and contributes 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
• Oversees set‑up and maintenance of study systems (e.g., CTMS, TMF) and ensures compliance with clinical trial registry requirements
• Identifies outsourcing needs and leads vendor engagement, contracting, and management; ensures CROs and third‑party vendors are aligned and delivering per scope of work
• Provides input into baseline budget and timeline development and management; ensures accurate budget management and scope change control for internal and external studies
• Leads study‑level risk assessment and mitigation; monitors site activation and monitoring visits and acts on deviations; leads development and oversees implementation of patient recruitment and retention strategies and responds to deviations from plan; and monitors data entry and query resolution against agreed metrics
• Manages study close‑out activities, including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability; contributes to clinical study report writing and review; and facilitates study‑level lessons learned
• Assigns tasks to Clinical Study Management staff and supports their deliverables; directly supervises CTM staff (work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight); recommends and participates in cross‑functional and departmental process improvements; and identifies innovative, globally informed approaches to study execution 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

Qualifications

• Bachelor’s degree and at least six years of relevant industry experience
• Extensive budget management expertise; a 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
• Experience with Phase IV/RWE preferred

Compensation

$128,600.00 - $210,000.00

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g., medical, dental, vision, life and disability), paid time off, and family support benefits.

Equal Opportunity Employment

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.