Manager Clinical Study Lead

The Manager Clinical Study Lead (CSL) may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out. The 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 requires on-site work 3 days per week in Basking Ridge, NJ, Armonk, NY, Dublin Ireland or Uxbridge, London. This role is NOT eligible for fully remote work.

A typical day in this role looks like:

• 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 Lead (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.
• 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 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 require up to 25% travel.

This role may be for you if you have:

• Demonstrated interpersonal & leadership skills.
• Ability to understand and implement the operational strategic direction and guidance for respective clinical studies.
• A data driven approach to planning, executing, and problem solving.
• Effective 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 key stakeholders.
• Budget management experience.
• An awareness of relevant industry trends.
• Ability to build productive study teams and collaborations.
• Demonstrated vendor management experience.
• Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC.
• Experience in global clinical trial operations including experience developing protocols and key study documents.
• Knowledge of ICH/GCP and regulatory guidelines/directives.
• Effective project management skills, cross-functional team leadership and organizational skills.

In order to be considered qualified for this role, a minimum of a Bachelor's degree is required and 6+ years of direct clinical trial experience. Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents. You will also need technical proficiency trial management software and MS applications to be considered.

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.

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. 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.

Salary Range (annually)

$126,700.00 - $206,900.00

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