Manager Clinical Study Lead

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

Job summary

Regeneron is seeking a Manager, Clinical Study Lead to drive the global execution of smaller or less complex clinical trials from design through close-out. You will own study timelines and budgets, ensuring conduct aligns with SOPs and ICH/GCP, with oversight of CROs and internal teams.

The role requires a Bachelor’s degree and at least six years of industry experience, strong trial management systems knowledge, and budgeting expertise.

Qualifications

• Bachelor’s degree and at least six years of relevant industry experience.
• Experience managing global clinical studies and budgets.
• Strong knowledge of ICH/GCP and regulatory guidelines.
• Proven ability to lead cross-functional study teams.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery within timelines and budget.
• Provides input into protocol development and site evaluation; leads investigator meeting prep and execution.
• Oversees study documentation, data management plans, monitoring plans, and related materials.
• Manages study setup and maintenance of study systems (CTMS, TMF) and ensures regulatory compliance.
• Identifies outsourcing needs and oversees CRO/vendor engagement and budgets.

Skills

Budget management

Project management

Cross-functional leadership

Trial management systems

Microsoft Office (Project, PowerPoint,

Education

Bachelor’s degree

Tools

IVRS/IWRS

EDC

CTMS

Job description

Build Our Future Together

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 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.

Build Our Future Together

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 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.

When & Where

• Work Location: Armonk, NY, Warren, NJ
• 25% Travel may be required

Discover Your Role

• 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

This Role Requires

• Bachelor’s degree and have 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

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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$128,600.00 - $210,000.00