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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. The Senior CSL is 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. Contributes and drives ongoing process improvement initiatives.

This role is not eligible fully remote. This role is required to be onsite in one of our locations.

• 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

• Provides operational input into protocol development

• 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

• Leads the feasibility assessment to select relevant regions and countries for the study

• Oversees/conducts site evaluation and selection

• Leads investigator meeting preparation and execution

• 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

• Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work

• 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

• 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 and departmental process improvement initiatives

• 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

• Exceptional interpersonal & leadership skills

• 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

• Advanced communication skills via verbal, written and presentation abilities

• 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

• Strong budget management experience

• An awareness of relevant industry trends

• Ability to build, lead and develop productive study teams and collaborations

• 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.