Manager, Clinical Study Lead

As a Clinical Study Lead (CSL), you will lead the cross-functional study team responsible for the global execution of large, complex clinical trials from study design through study close out. These responsibilities apply to both internally sourced studies and studies outsourced to CROs, so we need a CSL who has experience handling Third-Party Vendors. We need someone who can also give to and drive process improvement initiatives that support our rapidly growing organization. This is an exciting time to join our organization and have a direct impact on bringing life-saving treatments to the market.

This role requires on-site work 3 days per week in Basking Ridge, NJ or Armonk, NY.

A typical day as a Clinical Study Lead 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 studyProvides operational input into protocol developmentOversees 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 requirementsIdentifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors Provides input into baseline budget development and managementProvides input into baseline timeline development and managementLeads risk assessment and identifies risk mitigation strategies at the study levelLeads the feasibility assessment to select relevant regions and countries for the studyOversees/conducts site evaluation and selectionLeads investigator meeting preparation and executionMonitors progress for site activation and monitoring visits and acts on any deviations from planLeads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from planMonitors data entry and query resolution and acts on any deviations from agreed metricsEnsures accurate budget management and scope changes for internal and external studiesOversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliationEscalates 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 issuesOversees the execution of the clinical study against planned timelines, deliverables and budgetOversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sitesOversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of workEnsure clinical project audit and inspection readiness through the study lifecycleSupports internal audit and external inspection activities and contributes to CAPAs as requiredManages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountabilityContributes to clinical study report writing and reviewFacilitates and contributes to study level lessons learnedAssigns tasks to Clinical Study Management staff and supports their deliverablesRecommends and participates in cross-functional and departmental process improvement initiativesResponsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPsResponsible 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/oversightMay 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 monitoringMay require up to 25% travel

This Role May Be For You If

Demonstrated interpersonal & leadership skillsAbility to understand and implement the operational strategic direction and guidance for respective clinical studiesA data driven approach to planning, executing, and problem solvingEffective communication skills via verbal, written and presentation abilitiesProactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritizationAbility to influence and negotiate across key stakeholdersBudget management experienceAn awareness of relevant industry trendsAbility to build productive study teams and collaborationsDemonstrated vendor management experienceTechnical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDCExperience in global clinical trial operations including experience developing protocols and key study documentsKnowledge of ICH/GCP and regulatory guidelines/directivesEffective project management skills, cross-functional team leadership and organizational skills

To be considered for this opportunity you must possess a Bachelors’ degree with a minimum of 5+ years of relevant industry experience. Advanced degrees may be considered in lieu of relevant 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 steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$124,200.00 - $202,800.00