Manager, Clinical Study Operations

🔥 12 hours ago

🍂 Massachusetts – Remote

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💵 $115k - $135k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 15%

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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

• Support onboarding and ramp-up for the Clinical Study Operations team • Translate strategic priorities into a roadmap for the area, including initiative sequencing, process investment, and team growth • Oversee ClinOps execution across feasibility, site start-up, enrollment, monitoring, and close-out • Escalate risks and blockers to leadership with clear tradeoffs and options • Own ClinOps KPIs and goals, track progress in Asana, and report to leadership and cross-functional partners • Make issue-classification and escalation decisions, including complaint versus technical-issue calls and device reconciliation/invoicing decisions • Lead domain-level ClinOps initiatives such as process standardization, tooling rollouts, and dashboard/reporting improvements • Maintain and improve ClinOps SOPs, work instructions, and CTMS practices • Represent ClinOps in BD conversations, feasibility discussions, and Investigator Meetings • Manage working relationships with sponsors and CRO intermediaries; represent Beacon directly when escalated decisions require alignment or sign-off • Partner with Product, Engineering, Life Science, Data Science, and BD to keep trials on track and compliant

🎯 Requirements

• 6+ years of experience in clinical trial operations in biotech, medtech, or pharma • Bachelor's or advanced degree in a clinical or scientific field • 1-2+ years directly managing people, with a track record of hiring, coaching, and performance management • Ability to travel up to 15% of the time for Investigator Meetings, sponsor engagements, and site visits • Demonstrated ownership of the clinical trial lifecycle: start-up, recruitment strategy, enrollment, monitoring, data cleaning, and close-out • Working knowledge of GCP, FDA and global regulatory requirements • Experience with SOP development and QMS practices (Qualio or similar) • Comfortable ramping up quickly on proprietary CTMS/eTMF tooling; prior specific-tool experience not required • Experience working with CROs and vendors: selection support, day-to-day oversight, and relationship management • Strong cross-functional communication skills • Comfortable operating asynchronously across time zones in a remote-first, distributed organization • A bias toward simplicity — able to introduce the right level of process without adding unnecessary complexity

🏖️ Benefits

• Equity • PTO • Asynchronous work practices supporting a strong remote experience • In-person hubs in Boston, New York, and Paris • Remote-first, distributed organization

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