Clinical Study Operations Manager

Job not on LinkedIn

🔥 7 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $90k - $110k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

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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, 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.

🎯 Requirements

• 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