Clinical Trials Manager

ROLE SUMMARY - CLINICAL TRIAL MANAGER

The Clinical Trial Manager (CTM) will oversee multiple multi-site international clinical trials underway at Alto focusing on the development of biomarkers for mental health. They will be responsible for every aspect of the study, from enrollment, data collection, clinical personnel management, and communicating with management. We require solid experience overseeing clinical trials and value applicants wanting to work at a fast-paced startup, with excellent communication and teamwork skills, and a strong desire to improve mental health care.

ROLES AND RESPONSIBILITIES

  • Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements
  • Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents
  • Develop study budget and timelines with clear assumptions
  • Track overall spend for the study over the course of the study
  • Collaborate with regulatory team to prepare regulatory documents for submission to the FDA
  • Maintain Trial Master File
  • Manage Investigational Product (IP)
  • Manage safety reporting to sites and regulatory bodies
  • Procure and manage contracts with study vendors and investigative sites
  • Provide oversight of independent field monitors and other clinical vendors
  • Identification and contracting with new sites
  • Review monitoring trip reports and track resolution of all action items and protocol deviations
  • Monitor at investigative sites to evaluate study site and field monitor performance
  • Collaborate with medical experts, clinical study sites, and clinical study vendors
  • Some travel may be required
  • Manage activities assigned to direct reports
  • Provide frequent study updates to senior management upon request

QUALIFICATIONS AND EDUCATION REQUIREMENTS

  • A relevant health care qualification 
  • 5+ years of experience in global Phase 1-4 clinical trials
  • Preferred skills, Qualifications, Or Technical Proficiencies
  • Ability to implement and manage a clinical program
  • Strong organizational, written, and verbal communication skills
  • Experience in CNS trials
  • Able to collaborate effectively with the study team, cross-functional team members, and external partners
  • Attention to detail and ability to prioritize tasks to meet critical deadlines
  • Ability to travel up to 10% of time
  • Knowledge of ICH/GCP and FDA regulations