Clinical Study Operations Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $90k - $110k / year

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 12%

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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 • Support study startup, maintenance, and close-out activities for clients • Act as the primary point of contact for clinical sites • Provide research-site training 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 Zendesk and Asana • Provide site feedback to improve devices and workflows

🎯 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 • Additional languages are a bonus • Proactive mindset with ability to identify priorities and anticipate challenges • Meticulous attention to detail • 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 • Desire to learn more about analytics, statistics, machine learning, and clinical trials

🏖️ Benefits

• Equity • PTO • Robust 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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