Job Summary
A Senior Manager Clinical Study Lead (CSL) is responsible for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out.
Main Responsibilities:
* Accountable for study timelines, study budget, and ensuring 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 and is the primary point of contact for leadership and oversight for the assigned study.
* Provides operational input into protocol development, oversees and provides input to the development of study specific documentation, and ensures compliance with clinical trial registry requirements.
* Identifies outsourcing needs of the study, leads and oversees engagement, contracting and management of required vendors, and provides input into baseline budget development and management.
* Leads risk assessment and identifies risk mitigation strategies at the study level, oversees/conducts site evaluation and selection, and leads investigator meeting preparation and execution.
* Monitors progress for site activation and monitoring visits, acts on any deviations from plan, and develops and implements patient recruitment and retention strategies.
* Ensures accurate budget management and scope changes for internal and external studies, oversees and provides input to the study drug and clinical supplies forecasting, and escalates issues related to study conduct, quality, timelines or budget.
Requirements:
* Bachelors' degree with a minimum of 8 years of relevant industry experience.
* Advanced degrees may be considered in lieu of relevant experience.
* Direct experience managing global clinical trial operations, including experience developing protocols and key study documents.
* Technical proficiency in trial management software and MS applications.