Note: The job is a remote job and is open to candidates in USA. Natera is a global leader in cell-free DNA testing focused on oncology, women’s health, and organ health. The Manager, Clinical Trials will independently manage complex clinical trials from start-up through close-out, ensuring timelines, budgets, quality metrics, protocol compliance, and regulatory requirements are met. The role also oversees vendors and CROs, manages study-related activities and staff, and collaborates with cross-functional teams and external stakeholders.
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, 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
- 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
- Employee must pass post offer criminal background check
Skills
- Bachelor's degree in life sciences, or other relevant discipline required
- 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
- 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
- Advanced degree preferred
- Experience in managing CROs is preferred
Benefits
- Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
- Free testing for Natera employees and their immediate families
- Fertility care benefits
- Pregnancy and baby bonding leave
- 401k benefits
- Commuter benefits
- Generous employee referral program
Company Overview
Company H1B Sponsorship