Remote Clinical Study Operations Lead — GCP/ICH

Beacon Biosignals; United States; Remote; USD 90,000 - 110,000; Full time

Benefits offered by this job

Equity

PTO

Remote work

Office hubs

Job summary

Beacon Biosignals is seeking a Clinical Study Operations Manager to drive the operational delivery of clinical studies from startup to close-out. You will collaborate with sponsors, project teams, and sites to ensure timely, compliant study execution and high-quality data collection.

This fully remote role (US-wide) offers a contract-to-hire path, up to 10% travel, and in-person hubs in select cities. You will train sites on study protocols, monitor timelines, maintain GCP/ICH compliance, and

Qualifications

• 5+ years of experience in clinical project management or clinical operations roles.
• Strong organizational and project management skills.
• Excellent written and verbal communication skills in English; additional languages are a bonus.
• A proactive mindset with the ability to identify priorities and anticipate challenges.
• Meticulous attention to detail, ensuring accuracy in data collection and reporting.
• Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements.
• Knowledge of decentralized data collection, compliance and oversight while showing empathy for both patients and sites.

Responsibilities

• Collaborate with project teams to implement study startup activities, including communication planning, logistics, development of study documentation, and data configuration.
• Instill confidence with clients on study operations through start up, maintenance and close out activities.
• Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication.
• Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection.
• Monitor project progress, ensuring adherence to timelines, protocols, and quality standards.
• Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards.
• Foster a culture of quality within the ClinOps and Scientific teams by coaching peers on GCP requirements, documentation discipline, versioning, and complaint management.
• Address operational issues promptly, escalating through tools like Zendesk and Asana for resolution.
• Provide actionable feedback from research sites to inform improvements in devices and workflows.

Skills

Clinical project management

Organizational skills

English communication

Proactive mindset

Detail-oriented

GCP/ICH compliance

Decentralized data collection

Learning analytics

Job description

Beacon Biosignals is seeking a Clinical Study Operations Manager to drive the operational delivery of clinical studies from startup to close-out. You will collaborate with sponsors, project teams, and sites to ensure timely, compliant study execution and high-quality data collection.

This fully remote role (US-wide) offers a contract-to-hire path, up to 10% travel, and in-person hubs in select cities. You will train sites on study protocols, monitor timelines, maintain GCP/ICH compliance, and