Full-Time

TMF Specialist

Posted on 5/24/2024

Axsome Therapeutics Inc

Axsome Therapeutics Inc

501-1,000 employees

Develops therapies for central nervous system conditions

Biotechnology

Junior

New York, NY, USA

Requirements
  • Bachelor’s degree
  • Prior exposure to clinical research
  • At least 2 years of experience with electronic trial master file system(s)
  • Ability to work on-site Monday, Tuesday, and Thursday
Responsibilities
  • Assist in the set-up, review, and maintenance of study specific TMFs
  • Collect, review, and index essential documents in accordance with the TMF Structure
  • Act as TMF point-of-contact for Study Teams
  • Assist with the creation and maintenance of TMF study trackers
  • Provide updates at team meetings of relevant TMF findings
  • Conduct TMF quality reviews
  • Ensure TMF is always inspection ready
  • Assist in preparation for and participates in internal or external audits/inspections
  • Demonstrate technical and strategic knowledge of applicable regulatory requirements

Axsome Therapeutics Inc

Axsome Therapeutics Inc

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With a dedicated focus on developing therapies for central nervous system conditions—such as depression, Alzheimer’s disease agitation, and fibromyalgia—this company stands out by addressing critical unmet medical needs with promising products like AXS-05 and AXS-07. The firm fosters a culture deeply committed to innovation and the development of therapies with novel mechanisms of action, showcasing strong potential in the medical field and enhancing patient care in areas with limited treatment options.

Company Stage

IPO

Total Funding

$430.7M

Headquarters

New York, New York

Founded

2012

Growth & Insights
Headcount

6 month growth

12%

1 year growth

45%

2 year growth

277%