[Remote] Clinical Study Operations Manager

Note: The job is a remote job and is open to candidates in USA. Beacon Biosignals is transforming precision medicine for the brain through at-home EEG and cardiopulmonary signal platforms for clinical development and diagnostics. The Clinical Study Operations Manager will oversee the operational delivery of clinical studies from startup through close-out, coordinating with sponsors, project teams, and clinical sites while ensuring quality, compliance, and timely execution.

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

• 5+ years of experience in clinical project management or clinical operations roles
• Strong organizational and project management skills, with the ability to manage multiple responsibilities effectively
• Excellent written and verbal communication skills in English
• A proactive mindset with the ability to identify priorities and anticipate challenges
• Meticulous attention to detail, ensuring accuracy in 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 while showing empathy for both patients and sites
• Additional languages are a bonus
• A desire to learn more about analytics, statistics, machine learning, and clinical trials

Benefits

• Fully remote anywhere in the U.S.
• Beacon's robust asynchronous work practices ensure a first-class remote work experience
• In-person office hubs available in Boston, New York and Paris
• Equity
• PTO
• Other benefits

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