Job Description
The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and accountability for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out.
* Leads cross-functional study team responsible for clinical study delivery and primary point of contact for leadership and oversight for assigned study.
* Provides operational input into protocol development and oversees development of study specific documentation including case report forms (CRF), data management plan, monitoring plan, etc.
* Ensures compliance with clinical trial registry requirements and oversees set-up and maintenance of study systems including Clinical Trial Management System (CTMS), Trial Master File (TMF), etc.
Responsibilities:
* Identifies outsourcing needs of study and leads engagement, contracting, and management of required vendors.
* Provides input into baseline budget development and management and provides input into baseline timeline development and management.
* Leads risk assessment and identifies risk mitigation strategies at study level and leads feasibility assessment to select relevant regions and countries for study.
Requirements:
* Exceptional interpersonal & leadership skills and ability to influence and negotiate across wide range of stakeholders.
* Advanced communication skills via verbal, written, and presentation abilities and proactive approach to meeting deadlines and effective use of time.
* Ability to build, lead, and develop productive study teams and collaborations and advanced technical proficiency in trial management systems and MS applications.
Education:
Bachelor's degree with minimum 8 years of relevant industry experience or advanced degrees may be considered in lieu of relevant experience.