Clinical Study Operations Manager

2 weeks ago
Full-time
Mid Level
Project and Program Management
Beacon Biosignals

Beacon Biosignals

Beacon Biosignals uses AI and EEG to transform brain disorder treatment with neurobiomarker technology, accelerating clinical trials and enhancing precision neurology.

Biotechnology
11-50
Founded 2019
$27M raised

Description

  • Lead study startup activities, including communication planning, logistics, study documentation, and data configuration.
  • Oversee site onboarding, training, and ongoing operational support throughout the study lifecycle.
  • Serve as the primary point of contact for clinical sites and maintain clear, timely communication.
  • Partner with sponsors and internal project teams to ensure efficient study execution.
  • Monitor study progress and keep activities aligned with timelines, protocols, and quality standards.
  • Maintain compliance with GCP, ICH guidelines, and other regulatory requirements.
  • Coach internal teams on GCP, documentation discipline, version control, and complaint management.
  • Escalate and resolve operational issues using tools such as Zendesk and Asana.
  • Collect and relay site feedback to improve devices and workflows.

Requirements

  • Experience in clinical project management or clinical operations roles.
  • Strong organizational and project management skills with the ability to manage multiple responsibilities.
  • Excellent written and verbal communication skills in English; additional languages are a bonus.
  • Proactive mindset with the ability to identify priorities and anticipate challenges.
  • Meticulous attention to detail for accurate data collection and reporting.
  • Ability to work in a fast-paced environment with multiple priorities.
  • Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements.
  • Knowledge of decentralized data collection, compliance, and oversight.
  • Empathy for both patients and sites.
  • Interest in learning more about analytics, statistics, machine learning, and clinical trials.
  • Preference for candidates based in the U.S. Central Time zone.

Benefits

  • Fully remote role with asynchronous work practices.
  • In-person office hubs available in Boston, New York, and Paris.
  • Salary range of $90,000–$110,000.
  • Equity included in the total compensation package.
  • PTO included in the total compensation package.

Interested in this position?

Apply directly on the company website

Apply Now

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