**Clinical Study Lead (CSL) Role Overview:**
The Clinical Study Lead (CSL) is accountable for the global execution of assigned smaller or less 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.
The CSL oversees cross-functional study teams responsible for clinical study delivery and is the primary point of contact for leadership and oversight (as required) for the assigned study.
The role requires on-site work 3 days per week in Basking Ridge, NJ, Armonk, NY, Dublin Ireland or Uxbridge, London.
Key Responsibilities:
* Leads the cross-functional study team responsible for clinical study delivery
* Primary point of contact for leadership and oversight (as required) for the assigned study
* Provides operational input into protocol development
* Oversees and provides input to the development of study specific documentation
* Ensures compliance with the 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
* Leads the feasibility assessment to select relevant regions and countries for the study
* Monitors progress for site activation and monitoring visits and acts on any deviations from plan
Requirements:
* Demonstrated interpersonal & leadership skills
* Ability to understand and implement the operational strategic direction and guidance for respective clinical studies
* Data driven approach to planning, executing, and problem solving
* Effective communication skills via verbal, written and presentation abilities
* Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
* Budget management experience
* An awareness of relevant industry trends
* Ability to build productive study teams and collaborations
* Demonstrated vendor management experience
* Technical proficiency in trial management systems and MS applications including (but not limited to) Project, Power Point, Word, Excel, IVRS/IWRS, EDC
Qualifications:
* A minimum of a Bachelor's degree
* 6+ years of direct clinical trial experience
* Direct experience managing global clinical trial operations
* Technical proficiency in trial management software and MS applications