accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out
ensures study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP
leads the cross-functional study team responsible for clinical study delivery
oversees execution against planned timelines, deliverables, and budget while escalating issues to the Program Operations Lead
provides operational input into protocol development
oversees or conducts site evaluation and selection
leads investigator meeting preparation and execution
manages study close-out activities, including database lock, reconciliation of vendor contracts, and budget

Bachelor’s degree
at least six years of relevant industry experience
extensive budget management expertise
proven ability to build productive study teams and collaborations
demonstrated vendor management experience
strong technical proficiency with trial management systems and Microsoft applications (Project, PowerPoint, Word, Excel)
experience in global clinical trial operations, including developing protocols and key study documents
solid knowledge of ICH/GCP and relevant regulatory guidelines and directives
effective project management, cross-functional team leadership, and organizational skills

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)

Manager, Clinical Study Lead

Key skills