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
accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP
lead 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
provide operational input into protocol development
oversee and provide 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.
oversee set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
ensure compliance with the clinical trial registry requirements
identify outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
provide input into baseline budget development and management
provide input into baseline timeline development and management
lead risk assessment and identifies risk mitigation strategies at the study level
lead the feasibility assessment to select relevant regions and countries for the study
oversee/conduct site evaluation and selection
lead investigator meeting preparation and execution
monitor progress for site activation and monitoring visits and acts on any deviations from plan
lead the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
monitor data entry and query resolution and acts on any deviations from agreed metrics
ensure accurate budget management and scope changes for internal and external studies
oversee and provide input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
escalate 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
oversee the execution of the clinical study against planned timelines, deliverables and budget
oversee data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
oversee and ensure 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
support internal audit and external inspection activities and contributes to CAPAs as required
manage and oversee study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
contribute to clinical study report writing and review
facilitate and contribute to study level lessons learned
assign tasks to Clinical Study Management staff and supports their deliverables
recommend and participate 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

Requirements

minimum of a Bachelor's degree is required
minimum of 8 years relevant clinical trial 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

Benefits

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave) for eligible employees at all levels

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial managementbudget managementprotocol developmentdata managementrisk assessmentpatient recruitment strategiesvendor managementproject managementdata quality oversightstudy close-out activities

Soft Skills

interpersonal skillsleadership skillscommunication skillsnegotiation skillstime managementprioritizationproblem solvingteam buildingcoachingmentoring