Clinical Study Operations Manager

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $90k - $110k / year

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 14%

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Logo of Beacon Biosignals

Beacon Biosignals

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

• Ensure successful operational delivery of Beacon’s clinical studies from startup through close-out • Collaborate with project teams on study startup activities, including communication planning, logistics, study documentation, and data configuration • Oversee study startup planning, site onboarding and training, and ongoing operational oversight • Act as the primary point of contact for clinical sites • Provide training to 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 through tools such as Zendesk and Asana • Provide feedback from research sites to improve devices and workflows • Work with sponsors, project teams, and clinical sites to identify risks and maintain stakeholder alignment

🎯 Requirements

• 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; 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 • 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 • A desire to learn more about analytics, statistics, machine learning, and clinical trials

🏖️ Benefits

• Equity • PTO • Asynchronous work practices • Fully remote work • In-person office hubs available in Boston, New York, and Paris • Up to 10% travel

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