Clinical Study Operations Manager

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Beacon Biosignals

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Beacon Biosignals is a company focused on powering precision medicine for the brain. Their EEG neurobiomarker platform is engineered to accelerate clinical trials and enable new treatments for patients with neurological and psychiatric diseases. The platform captures a rich array of the brain's activity in real time and utilizes machine learning to analyze EEG data for treatment efficacy, dose selection, and population stratification. Beacon Biosignals partners with biopharma companies, academic medical centers, and neurotechnology developers to improve the diagnosis and treatment of neurological and psychiatric diseases.

📋 Description

• Collaborate with project teams to implement study startup activities, including communication planning, logistics, study documentation development, and data configuration • Build client confidence in study operations through startup, maintenance, and close-out activities • Serve as the primary point of contact for clinical sites • Train research sites on Beacon’s devices and study protocols • Monitor project progress and adherence to timelines, protocols, and quality standards • Maintain compliance with GCP, ICH guidelines, and regulatory standards • Coach peers on GCP requirements, documentation discipline, versioning, and complaint management • Address operational issues and escalate them through Zendesk and Asana • Provide feedback from research sites to improve devices and workflows • Ensure successful operational delivery of clinical studies from startup through close-out

🎯 Requirements

• 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 • Proactive 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 patients and research sites • Desire to learn about analytics, statistics, machine learning, and clinical trials

🏖️ Benefits

• Contract-to-hire opportunity • Fully remote work anywhere in the U.S. • Asynchronous work practices • In-person office hubs available in Boston, New York, and Paris • Equity • PTO • Other benefits included in the total compensation package