Job Description:
The Clinical Study Lead is responsible for the global execution of assigned clinical trials from design to close out. This includes overseeing cross-functional study teams, providing operational input into protocol development, and ensuring compliance with ICH/GCP and company SOPs.
Responsibilities:
* Led the feasibility assessment to select relevant regions and countries for the study
* Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF)
* Ensures accurate budget management and scope changes for internal and external studies
* Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
Requirements:
* Bachelor's degree in a related field
* Minimum 8 years experience in global clinical trial operations
* Advanced project management skills, cross-functional team leadership and organizational skills
Benefits:
We have an inclusive and diverse culture that provides comprehensive benefits which include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.