Senior Clinical Study Lead Job Description
The Senior Mgr Clinical Study Lead (CSL) is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out.
This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly.
Key Responsibilities:
* Leads the cross-functional study team responsible for clinical study delivery
* Provides operational input into protocol development
* Oversees and provides input to the development of study specific documentation
* Ensures compliance with clinical trial registry requirements
* Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
* Provides input into baseline budget development and management
* Leads risk assessment and identifies risk mitigation strategies at the study level
* Monitors progress for site activation and monitoring visits and acts on any deviations from plan
Requirements:
* Exceptional interpersonal & leadership skills
* Advanced expertise in clinical study operations
* Expert knowledge of data driven approach to planning, executing, and problem solving
* Strong budget management experience
* Ability to influence and negotiate across a wide range of stakeholders
* Advanced technical proficiency in trial management systems and MS applications
* Extensive experience in global clinical trial operations
Education and Experience:
A Bachelors degree with a minimum of 8 years of relevant industry experience. Advanced degrees may be considered in lieu of relevant experience.