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Axsome Therapeutics

Biopharmaceutical company developing CNS disorder therapies

Manager, Clinical Budgets and Contracts

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeNew York, NY, USA

About the Job

Requirements

  • A bachelor's degree from an accredited college or university is required.
  • At least 5 years of experience in the clinical research industry, including at least 3 years of direct budget negotiation experience, is required.
  • Strong analytical skills are required, including advanced proficiency in Excel and the ability to quickly manipulate and analyze large data sets and build reports.
  • Experience using project management tools such as Smartsheet and data processing tools such as Power BI is required.
  • The role requires working on site Monday, Tuesday, and Thursday; fully remote candidates are not considered.
  • Strong knowledge of clinical trials and Good Clinical Practice (GCP) is required.
  • The candidate must be self-driven and able to work independently and collaboratively in a fast-paced team environment.
  • The candidate must be able to adapt to changing priorities and deadlines.

Responsibilities

  • Lead the development of clinical trial site budgets in conjunction with the study team.
  • Build and perform quality control of finalized site budget templates in the site payment system.
  • Lead negotiation of clinical trial site budgets and payment terms, and liaise with Legal on contract negotiations as needed.
  • Perform internal quality control review of finalized site budgets.
  • Participate in vendor evaluations and lead vendor budget and contract negotiations for assigned vendors or trials.
  • Function as the Site Payment Lead for assigned clinical trials.
  • Address site invoicing queries and facilitate visit and invoice payment approvals.
  • Generate site payment reports as needed.
  • Assist with subject visit accrual and accrual validation for assigned trials.
  • Assist with subject visit and subject visit cost forecasting by working with study teams to understand protocol design and realistic study timelines.
  • Work with Data Management and Finance to ensure accurate site budget template builds and timely site payments from start-up through close-out.
  • Assist with annual reporting of site investigator payments to CMS in collaboration with Compliance and Finance.
  • Work with Finance and study teams to reconcile site payments and facilitate study close-out payments.
  • Maintain a repository of site master budgets and research fee dashboards to support transparent site and study budget comparisons.
  • Support the financial audit process as needed.
  • Identify opportunities to enhance existing procedures and improve utilization of financial system tools.
  • Support and lead project initiatives related to the role.
  • Perform other related duties as assigned.

About the Company

Axsome Therapeutics

Biopharmaceutical company developing CNS disorder therapies

Axsome Therapeutics develops therapies for central nervous system disorders. Its focus is on research, development, and commercialization of treatments for conditions such as major depressive disorder, treatment-resistant depression, Alzheimer's agitation, migraine, narcolepsy, fibromyalgia, and smoking cessation. The flagship product candidate, AXS-05, is an oral NMDA receptor antagonist intended to treat MDD and TRD; it works by blocking NMDA receptors to influence brain signaling involved in mood and depression, and has received FDA Breakthrough Therapy Designation. The company earns revenue from the commercialization of its drugs, partnerships, and potential licensing deals as its pipeline progresses through clinical trials and regulatory approvals. Axsome aims to provide effective CNS therapies, advance its drug pipeline, and improve patient outcomes and quality of life.

Company size
501-1,000
Company stage
IPO
Headquarters
New York City, New York
Founded
2012

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