Alto Neuroscience, Inc.
  • Los Altos, CA, USA
  • Full Time

About Alto Neuroscience

Alto Neuroscience is developing a new generation of precision therapeutics for the treatment of mental illnesses, based on a platform built on large-scale biomarker data, clinical outcomes and cutting-edge artificial intelligence analysis tools. The team combines world-leading neuroscientists, engineers and business executives with a singular focus on transforming the diagnosis and treatment of mental illnesses.

Currently, there is no objective way to diagnose psychiatric illness, nor to identify which treatment is best for an individual patient. Treatment selection is presently done by trial-and-error as there are no reliable blood tests nor objective brain measures, for example, that can inform these decisions. Alto is focused on addressing this need by developing new medications that are more effective by virtue of being personalized -- whereby each person gets the right drug for their brain. Come join us on our mission to re-imagine and re-engineer the treatment of mental illnesses!


Job description

The CTS Coordinator ensures planning, procurement, preparation and distribution of all clinical trial supplies and oversight of investigational product distribution according to project timelines and GMP standards.

Responsibilities

  • In collaboration with clinical project management, develop and execute the clinical trial supplies plan according to clinical study timelines and budget
  • Develop and execute the clinical trial supplies distribution plan according to sites' recruitment rate and enrolment plan
  • Being responsible for IP shipment orders according to supply plans or as requested by Clinical Project Management to ensure timely shipment and delivery to investigator sites.
  • Track all aspects of clinical supply shipment, storage, and usage at sites, and monitor site inventory levels. Maintain accurate and up-to-date reports as required.
  • Managing IP inventory, advising team of potential shortages and making recommendations for resupply activities based on usage trends
  • Develop and utilize IRT systems to ensure reliable and efficient clinical supply to depots and sites. Adjust system settings based on study progress and changes to supply assumptions.
  • Assist with the design and approval of investigational product labels
  • Prepare and deliver clinical trial supply presentation materials and specific training on Investigational products at Investigator Meetings, CRA meetings or Site Initiation Visit as needed.
  • Ensure that projects follow approved processes and SOPs, and adhere to GMP/GCP requirements and guidelines
  • Reconcile clinical trial supplies upon trial conclusion.
  • Ensure proper documentation of clinical supply activities for filing in the Trial Master File.
  • Assist with the sourcing and procurement of additional CTS materials, as needed.
  • Completes various tasks within the Clinical area such as review and updates of SOPs.

Requirements

  • Scientific degree (Pharmacy, Biotechnology or Biology)
  • Prefer 2-3 years' experience in a clinical research or clinical trial supply position.
  • Working knowledge of drug development and clinical research
  • Working knowledge of GMP, GCP and good documentation practices
  • Net-working and team working
  • Action and results driven
  • Ability to manage stress
  • Analytical skills
  • Capable of planning and anticipating actions according to changing priorities and deadlines
  • Capable of working efficiently in a team environment to assist with multiple clinical projects
  • Capable of creating and maintaining good relations
  • Excellent oral and written communication skills
Alto Neuroscience, Inc.
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