Senior Manager, Clinical Trial

Summary

Join Natera as a Senior Manager, Clinical Trial and play a pivotal role in managing all aspects of clinical trials for the development and commercialization of non-invasive molecular diagnostic tests. You will lead clinical operations staff, independently managing study design, protocol implementation, site monitoring, and recruitment. Responsibilities include implementing clinical trial activities, managing junior staff, overseeing study contracting and budgeting, and collaborating with various teams. You will design study documents, train personnel, monitor trial progress, and partner with other R&D groups. This position requires regular handling of PHI and necessitates HIPAA/PHI privacy training. The role demands strong leadership, communication, and organizational skills.

Requirements

• 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
• 1-2 years of experience of managing staff
• Experience managing all aspects of the trials independently, including study design, protocol implementation, site monitoring, 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

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 junior clinical research staff (e.g. CRA, CTA)
• 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

Preferred Qualifications

• Advanced degree preferred
• Experience in managing CROs is preferred

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
• We also offer a generous employee referral program!