Summary/Position Objective

The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global/regional/country 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.

Job Duties

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

Supports 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)/Country Operations Lead (COL) 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

May be 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

Job Requirements

Bachelors degree and minimum of 8 years relevant industry experience.

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 (Preferred)

Does this sound like you? Apply now to take your first step towards living the Regeneron Way 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 in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S.

law and apply to U.S.-based positions.

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.

If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.

Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.

The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

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