Specialist/Senior Specialist, Clinical Budgets and Contracts

About This Role

Axsome Therapeutics is seeking a Specialist/Senior Specialist, Clinical Budgets and Contracts to assist in the financial oversight of Axsome-sponsored clinical trials. Reporting to the Associate Director, Clinical Budgets and Contracts, this role will lead CDA review and processing through execution, develop and negotiate site budgets from study start-up through close-out, and support site payments. The role will work closely with the Finance, Legal and Clinical teams.

Job Responsibilities and Duties

• Lead the review and execution of CDAs and NMDAs for Clinical and liaise with Legal, as needed
• Develop clinical trial site budgets for assigned trials and incorporate feedback from the study team
• Negotiate clinical trial site budgets and payment terms for assigned trials, and liaise with Legal on contract negotiations, as needed
• Assist in building site organizations and contacts, site budgets, and payment terms in the site payment system
• Maintain a master site budget tracker for assigned trials
• Maintain accurate and up-to-date contract files, databases, and workflow trackers
• Monitor study CTA milestones and deadlines to ensure timely completion
• Facilitate QC review and execution of finalized clinical trial agreements, as needed
• Support the site payment process from study start-up through payment query resolution throughout the study period
• Support responses to queries in the Site Payments Inbox, as needed
• Support accruals, expenses, and payment reporting, as needed
• Support the Finance team audit process, as needed
• Participate in identifying and discussing opportunities to enhance existing procedures and improve utilization of financial system tools
• Perform other related duties as assigned

Requirements / Qualifications

• Bachelor’s degree from an accredited college or university
• 1–3 years of experience in the pharmaceutical, biotechnology, or clinical research industry, including at least 1–2 years of direct budget negotiation experience
• Excellent analytical skills, including advanced proficiency in Excel and the ability to quickly manipulate and analyze large data sets and build reports
• Ability to work on site Monday, Tuesday, and Thursday. We are unable to consider candidates seeking fully remote roles

Experience, Knowledge and Skills

• Strong knowledge of clinical trials and Good Clinical Practice (GCP)
• Experience with project management tools such as Smartsheet is a plus
• Experience with data processing tools such as Power BI is a plus
• Self-driven, with the ability to work independently and collaboratively, as required, in a fast-paced team environment
• Strong ability to adapt to changing priorities and deadlines