Job Title:
Senior Manager Clinical Study Lead
Job Description:
* The Senior Clinical Study Lead operates with a high-degree of independence and is accountable for the execution of assigned clinical trials from design through close out.
* They are accountable for study timelines, budgets, and ensuring study conduct aligns with standard operating procedures and regulatory guidelines.
* This role involves leading cross-functional teams, overseeing protocol development, and providing input to key study documents.
* It also requires managing study systems, identifying outsourcing needs, and negotiating with vendors.
* The successful candidate will have advanced project management skills, leadership abilities, and expertise in trial management systems.
* Additionally, they must have extensive experience in global clinical trial operations and knowledge of industry trends.
Required Skills and Qualifications:
* Exceptional interpersonal and leadership skills
* Advanced expertise in operational strategic direction and guidance for clinical studies
* Demonstrated knowledge and data-driven approach to planning and problem-solving
* Strong budget management experience
* Awareness of relevant industry trends
* Ability to build and lead productive study teams and collaborations
* Advanced negotiation and interpersonal skills for vendor management
* Technical proficiency in trial management systems and MS applications
* Extensive experience in global clinical trial operations
* Knowledge of ICH/GCP and regulatory guidelines
* Advanced project management skills, cross-functional team leadership, and organizational skills
* Line management experience
Benefits:
We offer a comprehensive benefits package that includes health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Others:
Regeneron is an equal opportunity employer and values diversity and inclusion in the workplace.