Lead Clinical Study Manager
The successful candidate will lead cross-functional teams in the delivery of large and complex clinical trials from design to close-out. They will be accountable for ensuring timely execution, budget management, and compliance with regulatory guidelines. A key focus will be on developing and implementing operational strategic direction, leveraging expertise to drive process improvement initiatives.
Key Responsibilities:
* Operate with high-degree independence and accountability for global clinical trial execution
* Provide operational input into protocol development and oversee study-specific documentation
* Identify outsourcing needs, engage vendors, and manage required contracts
* Manage risk assessment and mitigation strategies at the study level
* Oversee feasibility assessments, site evaluations, and investigator meetings
* Develop and implement patient recruitment and retention strategies
* Monitor data entry, query resolution, and ensure accurate budget management
* Escalate issues related to study conduct, quality, timelines, or budget to stakeholders and develop actions to address these
* Ensure clinical project audit and inspection readiness through the study lifecycle
* Contribute to clinical study report writing and review, facilitating and contributing to study-level lessons learned
Requirements:
* Exceptional interpersonal and leadership skills
* Advanced expertise in clinical trial operations with unique knowledge and skills
* Strong budget management experience
* Proactive and self-disciplined with ability to meet deadlines, prioritize tasks effectively
* Ability to influence and negotiate across a wide range of stakeholders
* Technical proficiency in trial management systems and MS applications
* Extensive experience in global clinical trial operations
* Line management experience with strong organizational skills
Benefits:
* Inclusive and diverse work culture
* Comprehensive benefits package including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off
* Equal opportunity employer with consideration for employment without regard to protected characteristics
Other:
A minimum of 8 years relevant clinical trial experience is required, along with a Bachelor's degree. Regeneron is an equal opportunity employer and welcomes applications from qualified candidates worldwide.