Senior Manager, Clinical Study Lead (Genetics Medicine, Hepatology)

The Senior Clinical Study Lead (CSL) operates with a 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. Responsibilities Leads the cross‑functional study team responsible for clinical study delivery and serves as the primary point of contact for leadership and oversight. Provides operational input into protocol development. Oversees and contributes to the development of study‑specific documentation including case report forms (CRF), data management plans, monitoring plans, statistical analysis plans, etc. Oversees set‑up and maintenance of study systems such as Clinical Trial Management System (CTMS) and Trial Master File (TMF). Ensures compliance with clinical trial registry requirements. Identifies outsourcing needs and leads engagement, contracting, and management of vendors. Contributes to baseline budget and timeline development and management. Leads risk assessment and identification of risk mitigation strategies. Leads feasibility assessment to select relevant regions and countries. Oversees site evaluation, selection, activation, and monitoring visits while addressing deviations. Leads development and oversight of patient recruitment and retention strategies. Monitors data entry and query resolution, ensuring agreed metrics are met. Manages accurate budget and scope changes for internal and external studies. Provides input on study drug and clinical supplies forecasting, accountability, and reconciliation. Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader and stakeholders, implementing corrective actions. Oversees execution of the study against planned timelines, deliverables, and budgets. Monitors data quality, reviewing metrics, protocol deviations, and non‑compliance. Ensures CROs and third‑party vendors deliver per scope of work. Prepares for and supports clinical project audit and inspection readiness. Supports internal audit and external inspection activities and contributes to CAPAs as required. Manages study close‑out activities including database lock, contract reconciliation, budget, TMF and 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 process improvement initiatives. Identifies innovative approaches to clinical study execution, including global considerations and continuous improvement of CTM SOPs. Might be assigned unmasked tasks such as handling investigational product, managing unmasked trial master files, reviewing unmasked data in the EDC, serving as point of contact for IVRS issues, and supporting unmasked clinical monitoring. Directly supervises CTM staff, managing work assignments, performance, recruitment, professional development, coaching, and compliance. May require 25% travel. Qualifications Exceptional interpersonal and leadership skills. Advanced expertise in operational strategy for clinical studies. Expert knowledge and data‑driven approach to planning, execution, and problem solving. Advanced communication skills (verbal, written, presentation). Proactive, self‑disciplined with strong time‑management and prioritization. Ability to influence and negotiate across a variety of stakeholders. Strong budget management experience. Awareness of industry trends, ICH/GCP and regulatory guidelines. Ability to build, lead, and develop productive study teams. Advanced negotiation and interpersonal skills in vendor management. Proficiency in trial management systems and Microsoft applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC). Extensive experience in global clinical trial operations, protocol development, and key study documents. Advanced project management, cross‑functional leadership, and organizational skills. Line management experience. Minimum of a Bachelor’s degree and at least 8 years of relevant clinical trial experience. Location & Travel This role requires onsite presence at one of Regeneron’s locations and is not available for fully remote work. The position may require up to 25% travel. Benefits Health, dental, vision, life, and disability insurance. Fitness center access. 401(k) company match. Family support benefits. Equity awards and annual bonuses. Paid time off and paid leaves (military, parental, etc.). 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, 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. #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc (USA)