The Senior Clinical Study Lead (CSL) is responsible for the global execution of assigned large and/or complex clinical trials. This role oversees study timelines, budget, and ensures conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP.
This position requires a high degree of independence and accountability. The Senior CSL works on internally sourced studies and those outsourced to Clinical Research Organizations (CROs), balancing direct leadership and oversight accordingly. Contributes to ongoing process improvement initiatives.
Key Responsibilities:
* Leads cross-functional study teams for clinical study delivery and serves as primary point of contact for leadership and oversight.
* Provides operational input into protocol development.
* Oversees development of study-specific documentation, including case report forms (CRF), data management plan, monitoring plan, etc.
* Ensures compliance with clinical trial registry requirements.
* Identifies outsourcing needs and leads vendor engagement, contracting, and management.
* Provides input into baseline budget and timeline development.
* Leads risk assessment and mitigation strategies at the study level.
* Conducts site evaluation and selection.
* Monitors progress for site activation and monitoring visits.
* Develops patient recruitment and retention strategies.
* Ensures accurate budget management and scope changes.
* Oversees study drug and clinical supplies forecasting and reconciliation.
* Escalates issues related to study conduct, quality, timelines, or budget.
* Manages study close-out activities, including database lock and vendor contract reconciliation.
* Supports clinical project audit and inspection readiness.
Requirements:
* Exceptional interpersonal and leadership skills.
* Advanced expertise in clinical study operations.
* Expert knowledge and data-driven approach to planning, executing, and problem-solving.
* Strong communication, negotiation, and interpersonal skills.
* Proactive and self-disciplined, with ability to meet deadlines and prioritize tasks.
* Ability to build and lead productive study teams and collaborations.
* Technical proficiency in trial management systems and MS applications.
* Experience in global clinical trial operations and regulatory guidelines/directives.
* Advanced project management and organizational skills.
* Line management experience.
Qualifications:
* Bachelor's degree with minimum 8 years relevant industry experience.
* Advanced degrees may be considered in lieu of relevant experience.
* Direct experience managing global clinical trial operations is required.
Regeneron is an equal opportunity employer and considers all qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, age, or any other protected characteristic.