Manager, Clinical Trials

United StatesRemote

Responsibilities

Manage the execution and conduct of all aspects of very complex clinical studies to ensure that timelines, cost, and quality metrics are met •
Manage study contracting, budget, forecasting, accruals and payment process for all clinical trial vendors including investigational sites •
Lead study-related activities such as protocol and informed consent preparation, investigator selection, study training material development and delivery, monitoring plans development and execution, CRFs, design and completion, TMF maintenance, protocol amendment and clinical report preparation, as required •
Collaborate with Clinical Data Management group to ensure correct CRFs content is collected, prepare comprehensive completion guidelines, and design effective data listings and study reports •
Train CROs, vendors, investigators and study coordinators on implementation of study protocol •
Hire, train, manage and oversee Clinical trial staff, and serve as a resource for others within the company for clinical trials management expertise •
Monitor and track clinical trial progress and provide status update to stakeholders •
Support sample management and prospective sample testing for studies where Natera functions as a central testing facility •
Develop Clinical Department SOPs and participate in audits as needed •

experience in managing all aspects of the trials independently, and is expected to provide functional expertise to ensure that study timelines, costs and quality metrics are met and the study is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements. PRIMARY RESPONSIBILITIES: •
Must maintain a current status on Natera training
Employee must pass post offer criminal background check
Bachelor’s degree in life sciences, or other relevant discipline required, Advanced degree preferred. •
experience in managing clinical trials as a leading role. • 4-7 years of
experience in supporting clinical trials in a regulated environment . •
Experience in managing CROs is preferred.
Knowledge and understanding of Clinical Trial SOPs, FDA Regulations, and ICH-GCPs governing the conduct of clinical trials •