Role Summary
Supports the Clinical Medical Contracting Center of Excellence by administering contractual agreements related to clinical research activities. This role is crucial for ensuring that all clinical trials and related activities adhere to legal, regulatory, and ethical standards, as well as internal policies, while minimizing risk and supporting clinical research objectives. This individual will work closely with legal to ensure clinical contracts are fully executed in a timely manner by reviewing budgets and business terms, managing vendor communication, and tracking activities.
Responsibilities
- Collaborates with Clinical Outsourcing (or designee) in processing MSAs, Work Orders, Service Agreements, Consulting Agreements, CDAs, and other agreements
- Ensure all contracts comply with FDA regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies
- Ensures on-time processing of all assigned contracts from initial request through execution in accordance with the project timelines
- Provides contract administration support for departments within Clin Med including Clinical Operations, Clinical Development, Clin Ops, Drug Safety and Pharmacovigilance, Experimental Medicine, and Analytics and Data Sciences
- Maintains trackers and accurately uses internal systems (Coupa and Agiloft) across multiple projects
- Serves as the primary point of contact for internal departments (e.g., legal, finance, clinical operations) and external parties (e.g., vendors, consultants) on contract matters
- Participates in the development and improvement of contract management tools, templates, and processes to enhance efficiency in clinical contracting
- Works collaboratively with assigned study teams in developing, implementing and ensuring NBI standard processes across clinical programs
- Other duties as assigned
Qualifications
- Understands Neurocrine's business objectives and develops understanding of Neurocrine's services and customers
- Experience in a functional discipline while working to acquire higher-level knowledge and skills
- Interpersonal and communication skills and experience supporting multiple teams
- Project management skills
- Works to improve tools and processes within the functional area
- Comfortable with tools and processes that support work conducted by the functional area
- Knowledge of the Clinical Trial process, regulations and guidelines
- Ability to read and interpret contracts and ensure contract language/terms meet company standards
- Ability to work as part of a cross-functional project team
- Contract administration skills, including budgeting, billing/invoicing, issue resolution, and acting as point of contact for CRO
- Knowledge of clinical contract accounting and budgeting process
- Excellent interpersonal and communication skills and experience supporting multiple teams
- Can recommend best practices in the functional discipline and familiarity with broader underlying concepts of related business disciplines
- Detail oriented
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Education
- Bachelor's degree in relevant field
- Master's Degree in Business Administration or health care/science related field
Skills
- Strong computer skills with advanced knowledge in Microsoft Word and Excel
- Proficiency with contract management software and internal systems (e.g., Coupa, Agiloft)
- Interpersonal and communication skills with experience supporting multiple teams
- Problem-solving and analytical thinking abilities
- Cross-functional collaboration and relationship management