Remote Manager, Clinical Trials

The Manager, Clinical Trials will be responsible for managing all aspects of clinical trials from start-up through close-out. The Clinical Trial Manager should have 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. Manage the execution and conduct of all aspects of very complex clinical studies to ensure that timelines, cost, and quality metrics are met Responsible for selection of vendors/CROs and provide effective ongoing management to vendors/CROs working on the project to ensure compliance and execution of project deliverables within the approved budget, study timeline, and study protocol. Works closely with investigative site personnel, CROs, and other study vendors 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 Partner with other research and development groups to create a culture of mutual respect and focus on delivery of high-quality project results Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, Human Subjects Protection, and GCP training. Must maintain a current status on Natera training requirements including General Policies and Procedure Compliance and security training. Bachelor’s degree in life sciences, or other relevant discipline required, Advanced degree preferred. 8 years of clinical research experience, including at least 4 years of experience in managing clinical trials as a leading role. 4-7 years of experience in supporting clinical trials in a regulated environment . Knowledge and understanding of Clinical Trial SOPs, FDA Regulations, and ICH-GCPs governing the conduct of clinical trials Proficiency in MS Word, Excel and PowerPoint Good organization and planning skills Ability to prioritize and handle multiple tasks and projects in a fast-paced environment The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. Remote USA $Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. 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