Senior Manager, Clinical Study Lead

BioSpace; Armonk (NY); Hybrid; USD 151,000 - 246,000; Full time

Job summary

Regeneron is seeking a Senior Clinical Study Lead to join the Clinical Trial Management team in Armonk, NY, supporting Inflammation & Immunology trials. You will lead large, complex trials from design through close-out with global responsibility for timelines, budget, and quality in accordance with ICH/GCP and Regeneron SOPs.

This role requires extensive line management of CTM staff, cross-functional leadership, and oversight of study documentation, vendors, and trial systems (CTMS, TMF, EDC).

Qualifications

• Bachelor's degree required and at least 8 years of clinical trial experience.
• Experience with line management and strong interpersonal/leadership skills.
• Advanced trial management skills with MS Office and CTMS/EDC familiarity.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery.
• Oversees development of study documents (CRF, DMP, monitoring plans, SAP).
• Manages CTMS and TMF setup and maintenance.
• Identifies outsourcing needs and oversees vendor management.
• Contributes to budget and baseline timeline development and monitoring.
• Leads risk assessment and regional feasibility for studies.
• Oversees patient recruitment, retention, data entry, and query resolution.
• Oversees drug supply forecasting and reconciliation.
• Escalates issues to Program Operations Leader (POL) and implements actions.
• Manages study close-out activities including database lock and accounting.

Skills

Line management

Leadership

Interpersonal skills

Cross-functional collaboration

Project management

Deadline prioritization

Communication

Education

Bachelor's degree

Tools

CTMS

TMF

EDC

IVRS/IWRS

PowerPoint

Word

Excel

Job description

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Clinical Study Lead to join our Clinical Trial Management team, supporting our Inflammation & Immunology therapeutic area. The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. You will be 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 out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly.

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Clinical Study Lead to join our Clinical Trial Management team, supporting our Inflammation & Immunology therapeutic area. The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. You will be 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 out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly.

When & Where

• Work Location: Armonk, NY, Warren, NJ
• Work Model: Primarily on-site with hybrid flexibility
• Travel: 25% Travel may be required

Discover Your Role

• 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, 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

This Role Requires

• A minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience
• We are seeking experience with line management as well as 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
• We are seeking 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

Does this sound like you? We are committed to building a workplace with an inclusive culture. 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. If you have any questions, please speak with your recruiter.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

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

Salary Range (annually)

$150,500.00 - $245,500.00