Manager, Clinical Study Operations

🔥 5 minutes ago

🍂 Massachusetts – Remote

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💵 $115k - $135k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 18%

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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

• Lead and manage a team within Clinical Study Operations • Oversee end-to-end ClinOps execution across clinical studies, including feasibility, site start-up, recruitment, enrollment, data collection, monitoring, and close-out • Set expectations, coach day-to-day execution, escalate risks, and intervene in complex or high-stakes situations • Own and drive domain-level ClinOps goals and initiatives, including process standardization, tooling, data quality, and dashboard/reporting improvements • Translate strategic priorities into roadmaps for the team’s area and communicate them to stakeholders • 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 • Maintain and improve ClinOps SOPs, work instructions, and CTMS practices • Represent ClinOps in BD conversations, feasibility discussions, Investigator Meetings, deal shaping, SOW input, and site/study planning • Manage working relationships with sponsors and CRO intermediaries • Partner with Product, Engineering, Life Science, BD, and Data Science to keep trials on track and compliant • Support onboarding and ramp-up as the team grows • Report to the Director, Clinical Study Operations

🎯 Requirements

• 6+ years of experience in clinical trial operations in biotech, medtech, or pharma • Device-based trial experience a strong plus • Bachelor's or advanced degree in a clinical or scientific field • 1–2+ years directly managing people, including hiring, coaching, and performance management • Ability to travel up to 15% of the time • 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) • Ability to ramp up quickly on proprietary CTMS/eTMF tooling • Experience working with CROs and vendors • Strong cross-functional communication skills • Ability to work asynchronously across time zones in a remote-first, distributed organization • Bias toward simplicity and appropriate process design

🏖️ Benefits

• Equity • PTO • Remote-first asynchronous work practices • In-person hubs in Boston, New York, and Paris • Diverse and collaborative work environment

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