Job Description
POSITION SUMMARY: The Clinical Trial Manager 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. PRIMARY RESPONSIBILITIES: 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 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 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 Hire, train and oversee Clinical trial staff, and mentor junior clinical operations staff. Develop Clinical Department SOPs and participate in audits as needed This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job. 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. QUALIFICATIONS: 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 . Experience in managing CROs is preferred. KNOWLEDGE, SKILLS, AND ABILITIES: Knowledge and understanding of Clinical Trial SOPs, FDA Regulations, and ICH-GCPs governing the conduct of clinical trials Demonstrated analytical skills and ability to identify problems and solutions independently Ability to collaborate with the study team, cross functional team members and external collaborators Proficiency in MS Word, Excel and PowerPoint Good organization and planning skills Strong interpersonal skills and communication skills (both written and oral) Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment Must have excellent organizational and time management 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. This may differ in other locations due to cost of labor considerations. Remote USA $138,600—$173,300 USD OUR OPPORTUNITY 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. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pr
