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 Senior Manager, Clinical Trials manages clinical trial operations supporting the development, validation, and commercialization of non-invasive molecular diagnostic tests, including study design, protocol implementation, site monitoring, recruitment, and staff management.
Responsibilities
- Responsible for the implementation of clinical trial activities per study protocol. Works closely with investigative site personnel, CROs, and other study vendors
- Manage and coach clinical research staff
- Manage study contracting, budget and payment process for all clinical trial vendors including investigational sites
- Partner with department head to develop department procedures and develop infrastructure
- Design study related documents, including but not limited to study protocol, informed consent forms, CRFs, and regulatory binders
- Train CROs, vendors, investigators and study coordinators on study protocol and relevant
- Monitor and track clinical trial progress and provide status update to stakeholders
- Partner with other research and development groups to achieve deliverables
- 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 complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire
- Must maintain a current status on Natera training requirements
Skills
- Bachelor's degree in life sciences, other relevant discipline, or equivalent required
- 5-10 years of clinical research experience, including at least 3-5 years of experience in managing clinical trials as a leading role
- 2+ years of experience of managing staff
- Experience managing CROs is preferred
- Experience managing all aspects of the trials independently, including study design, protocol implementation, site monitoring, sample management, and recruitment site management
- Familiar with the clinical research regulations
- Ability to collaborate with the study team, cross functional team members and external
- 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
- Advanced degree preferred
Benefits
- Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- Natera employees and their immediate families receive free testing.
- Fertility care benefits.
- Pregnancy and baby bonding leave.
- 401k benefits.
- Commuter benefits.
- Generous employee referral program.
Company Overview
Company H1B Sponsorship