Clinical Trials Manager

Clinical Operations Manager

Leads and manages the operational activities to support planning, initiation, conduct and close out of assigned clinical studies (domestic and global studies). Manages studies using Contract Research Organizations (CROs) as well as managing internally run studies.

Your contributions (include, but are not limited to) :

• Ensures clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies
• Serves as primary point of contact for clinical operations aspects of assigned clinical studies
• Participates in technical and study design discussions and provides input to clinical trial outlines, protocols, and clinical study reports
• Manages contract research organizations (CROs) and other contract service providers (CSPs) for assigned studies
• Leads study team meetings and manages study issues. Develops and manages study timelines in accordance with corporate goals. Identifies barriers to enrollment and develops recruitment solutions
• Manages internally run studies (without CROs) including the management of CRAs and develops monitoring plans, on-site monitoring guidelines, forms, tools and performs onsite monitoring and co-monitoring visits, as necessary
• Works collaboratively with clinical operations department in developing, implementing and enforcing NBI standard processes across all clinical programs
• Other duties as assigned

Requirements :

Neurocrine Biosciences is an EEO / Disability / Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications dont line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $128,200.00-$185,900.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties / requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver / parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.