Sr. Specialist, Clinical Trials Operations

Neurocrine Biosciences • San Diego, CA

5d

About The Position

Leads efforts to support the centralized operational activities for assigned Clinical Studies. Centralized activities can include but are not limited to set up of studies, development of Informed Consent documents and study plans, handling IRB submissions of protocol/ICF/sites, management of the Trial Master File (TMF) and Financial Disclosure Forms, feasibility and selection of sites, coordination of committees (i.e. adjudication committees), support of site enrollment, and oversight of monitoring for studies outsourced to Contract Research Organizations (CROs). _ Your Contributions (include, but are not limited to): Ensures that centralized activities for 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 Works collaboratively with assigned study teams in developing, implementing and ensuring NBI standard processes across clinical programs Supports best practice and improved operational processes for execution of clinical trials Supports the development of processes, tools, templates, and applicable training related to centralized activities and/or monitoring oversight Supports generating metrics and reports to provide insights into cycle time for centralized activities and/or oversight of outsourced monitoring activities Works collaboratively with clinical operations department in documenting NBI standard processes across assigned clinical programs. May train and provide guidance to lower level Specialists Supports inspection readiness activities Other duties as assigned

Requirements

• BS/BA in Scientific field or equivalent and 4+ years of clinical trials or operations experience, CRO/Vendor Management exposure is preferred. Participation in monitoring clinical trials or related experience required OR Master's degree in Scientific field or equivalent and 2+ years of similar experience noted above
• Strong knowledge of the clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directives
• Solid understanding of clinical operations, specifically conducting clinical studies from start-up through close-out
• Trial management protocol and process understanding
• Solid understanding of Clinical Research industry and the relevant environments in which it operates
• Ability to design, plan and execute activities and works well under changing circumstances; manages time effectively
• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
• Works to improve tools and processes within functional area
• Ability to work as part of team and may train lower levels
• Excellent computer skills
• Strong communications, problem-solving, analytical thinking skills
• Sees impact on department and clinical function
• Ability to meet multiple deadlines across a project/program, with a high degree of accuracy and efficiency
• Strong project management skills
• Ability at analyzing data and information to derive options/recommendations for management considerations

Nice To Haves

• CRO/Vendor Management exposure is preferred.
• Participation in monitoring clinical trials or related experience required

Responsibilities

• Ensures that centralized activities for 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
• Works collaboratively with assigned study teams in developing, implementing and ensuring NBI standard processes across clinical programs
• Supports best practice and improved operational processes for execution of clinical trials
• Supports the development of processes, tools, templates, and applicable training related to centralized activities and/or monitoring oversight
• Supports generating metrics and reports to provide insights into cycle time for centralized activities and/or oversight of outsourced monitoring activities
• Works collaboratively with clinical operations department in documenting NBI standard processes across assigned clinical programs.
• May train and provide guidance to lower level Specialists
• Supports inspection readiness activities
• Other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees