Remote Clinical Study Ops Lead

CleveMed; Boston, Northern (MA, KY); Hybrid; USD 90,000 - 110,000; Full time

Job summary

Beacon Biosignals is transforming precision medicine for the brain, from clinical development to clinical care. Our at-home EEG platform supports clinical development of neurological, psychiatric, and sleep disorder therapeutics.

As a Clinical Study Operations Manager within the Clinical Study Operations team, you will ensure successful operational delivery of Beacon’s clinical studies from startup through close-out.

Qualifications

• 5+ years of experience in clinical project management or clinical operations roles.
• Strong organizational and project management skills.
• Excellent written and verbal communication in English; additional languages a bonus.
• Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements.
• Knowledge of decentralized data collection and oversight while showing empathy for patients and sites.
• Interest in analytics, statistics, machine learning, and clinical trials.

Responsibilities

• Collaborate with project teams to implement study startup activities, including planning, logistics, documentation, and data configuration.
• Provide training to research sites on device use and study protocols, ensuring proper data collection.
• Act as primary contact for clinical sites with clear communication and smooth operations.
• Monitor project timelines, ensuring adherence to protocols and quality standards.
• Identify risks and escalate operational issues using tools like Zendesk and Asana.
• Coach peers on GCP compliance, documentation discipline, versioning, and complaint management.

Skills

Project management

Communication skills

GCP knowledge

ICH guidelines

Regulatory awareness

Decentralized data

Job description

Beacon Biosignals is transforming precision medicine for the brain, from clinical development to clinical care. Our at-home EEG platform supports clinical development of neurological, psychiatric, and sleep disorder therapeutics.

As a Clinical Study Operations Manager within the Clinical Study Operations team, you will ensure successful operational delivery of Beacon’s clinical studies from startup through close-out.