Senior Manager, Clinical Study Lead

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. 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. This role is not eligible fully remote. 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.
Ensures compliance with the clinical trial registry requirements
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
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
Ensures accurate budget management and scope changes for internal and external studies
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
Oversees the execution of the clinical study against planned timelines, deliverables and budget
Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
Ensure clinical project audit and inspection readiness through the study lifecycle
Supports internal audit and external inspection activities and contributes to CAPAs as required
Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
Contributes to clinical study report writing and review
Assigns tasks to Clinical Study Management staff and supports their deliverables
Responsible for identification of innovative approaches to clinical study execution including global considerations 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
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
May require 25% travel
Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies
Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving
Strong budget management experience
Applies advanced negotiation and interpersonal skills to vendor management
Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents
Knowledge of ICH/GCP and regulatory guidelines/directives
Advanced project management skills, cross-functional team leadership and organizational skills
Line management experience
In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience.
We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels
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.
For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency.