About the Role
The Senior Clinical Study Lead (CSL) is a key position that operates with high independence and accountability for the global execution of assigned large and/or complex clinical trials.
Key Responsibilities:
* Lead cross-functional study teams responsible for clinical study delivery.
* Provide operational input into protocol development.
* Oversee and provide input to the development of study-specific documentation, including case report forms (CRF), data management plans, monitoring plans, etc.
* Evaluate and select relevant regions and countries for the study.
* Monitor progress for site activation and monitoring visits.
* Develop and oversee patient recruitment and retention strategies.
* Ensure accurate budget management and scope changes for internal and external studies.
* Escalate issues related to study conduct, quality, timelines, or budget to Program Operations Leader (POL).
Requirements:
* Bachelor's degree with a minimum of 8 years of relevant industry experience.
* Advanced degrees may be considered in lieu of relevant experience.
* Direct experience managing global clinical trial operations, including experience developing protocols and key study documents.
* Technical proficiency in trial management software and MS applications.
What We Offer:
A comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.