Senior Manager, Clinical Trials

<p><strong>POSITION SUMMARY:</strong></p> <p>This Senior Manager, Clinical Trial is responsible for managing all aspects of clinical trials to support the development, validation, and commercialization non-invasive molecular diagnostic tests. This role manages clinical operations staff and all aspects of the trials independently, including study design, protocol implementation, site monitoring, and recruitment site management.</p> <p>&nbsp;</p> <p><strong>PRIMARY RESPONSIBILITIES:</strong></p> <ul> <li> <p>Responsible for the implementation of clinical trial activities per study protocol. Works closely with investigative site personnel, CROs, and other study vendors</p> </li> <li> <p>Manage and coach clinical research staff.</p> </li> <li> <p>Manage study contracting, budget and payment process for all clinical trial vendors including investigational sites.</p> </li> <li> <p>Partner with department head to develop department procedures and develop infrastructure.</p> </li> <li> <p>Design study related documents, including but not limited to study protocol, informed consent forms, CRFs, and regulatory binders.</p> </li> <li> <p>Train CROs, vendors, investigators and study coordinators on study protocol and relevant</p> </li> <li> <p>Monitor and track clinical trial progress and provide status update to stakeholders.</p> </li> <li> <p>Partner with other research and development groups to achieve deliverables.</p> </li> <li> <p>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</p> </li> <li> <p>Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure&nbsp;Compliance&nbsp;training and security training as soon as possible but not later than the first 30&nbsp;days of hire.</p> </li> <li> <p>Must maintain a current status on Natera training requirements.</p> </li> </ul> <p>&nbsp;</p> <p><strong>QUALIFICATIONS:</strong></p> <ul> <li> <p>Bachelor’s degree in life sciences, other relevant discipline, or equivalent required. Advanced degree preferred.</p> </li> <li> <p>5-10 years of clinical research experience, including at least 3-5 years of experience in managing clinical trials as a leading role.</p> </li> <li> <p>2+ years of experience of managing staff. Experience in managing CROs is preferred.</p> </li> <li> <p>Experience managing all aspects of the trials independently, including study design,