About the Role:Responsible for leading and managing the operational activities to support planning, initiation, conduct and close out of Gene Therapy and Neurology Clinical Studies (domestic and global studies). Responsible for managing studies using Contract Research Organizations (CROs) as well as managing internally run studies.
Clinical Trials Manager for Parkinsons (can be Snr CTM title)
YOUR CONTRIBUTIONS Include, But Are Not Limited To • Ensuring clinical studies are conducted in compliance with FDA regulations, ICH guidelines, and NBI SOPs and policies. • Serving as primary point of contact for clinical operations aspects of assigned clinical studies. • Understanding of gene therapy and neurology clinical studies to participate in technical and study design discussions and providing input to clinical trial outlines, protocols, and clinical study reports. • Managing contract research organizations (CROs) and other contract service providers (CSPs) for assigned studies. • Leading study team meetings and managing study issues. Developing and managing study timelines in accordance with corporate goals. Identifying barriers to enrollment and developing recruitment solutions. • Managing internally run studies (without CROs) including the management of CRAs and developing monitoring plans, on-site monitoring guidelines, forms, tools and performing onsite monitoring and co-monitoring visits, as necessary. • Working collaboratively with clinical operations department in developing, implementing and enforcing NBI standard processes across all clinical programs. • Performing additional tasks and duties as assigned.
REQUIREMENTS: • BS or MS, or RN with a minimum of 5 years of CRA and Clinical Trial Manager experience in pharmaceutical industry/ Biotech or CRO. In some cases, a combination of education and prior directly related experience may be considered as equivalent. • Must have detailed knowledge of clinical drug development process including working knowledge of ICH, GCPs, and FDA regulations • Must have experience in Gene Therapy and Neurology clinical trials • Must have previous experience in a Clinical Trial Manager role • Must have experience in managing CROs (domestic and international) • Must have prior onsite monitoring experience This top company is an EEO/AA/Disability/Vets employer
At This top company - voted one of San Diego's top places to work in 2018 - we pride ourselves on having a strong, distinctive and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve patient suffering and enhance lives. What We Do : This biopharmaceutical company is focused on developing treatments for neurological and endocrine related disorders.