Clinical Operations Lead

We are seeking a Clinical Operations Lead to build and lead the data operations team at our Boston site. In the near term, you will be the responsible supervisor on shift in our 2-lab setup, combining hands-on healthy and clinical execution with real-time supervision, decision-making, and problem-solving in a technical research environment. You will be the go-to person on shift for both participants and staff.

Over the next 12-18 months, as the site scales into clinical operations, the role grows substantially: you will hire and lead your own team, own the SOPs and training curriculum the team runs on, and prepare the site for GCP-grade clinical trials.

• Serve as the senior authority during assigned shifts, reporting directly to the Site Head
• Manage and oversee daily shift operations in the clinical research lab, including participant flow and staff coverage in the early phases
• Supervise and support Clinical Data Operators during shifts
• Personally run healthy and clinical sessions, including participant onboarding and data collection - more in early phases, less as the team grows
• Handle complex or sensitive cases involving participants with mental health conditions, including real-time decision-making and escalation
• Act as the primary point of contact for unexpected issues during the shift
• Troubleshoot technical or operational issues that arise during studies
• Author and iterate the SOPs, training curriculum, and competency standards that the rest of the team will run on; ensure adherence to clinical protocols, safety guidelines, and data quality standards
• Maintain accurate documentation and incident reporting; over time, build the documentation discipline needed for GCP-grade clinical operations
• Collaborate closely with clinical coordination, recruitment, and global stakeholders to ensure smooth operational flow and business success
• Work in a fast-paced, technical, and shift-based environment

• A Bachelor's or Master's degree in Social Work, Psychology, Nursing, Occupational Therapy, Counseling, or a related human-services field
• Prior hands-on experience working with participants or patients in clinical, therapeutic, or research settings
• Comfort working with individuals facing mental health challenges, including the ability to recognize escalating situations and respond appropriately
• Maturity and the ability to stay calm under pressure
• Strong interpersonal and communication skills
• Comfort operating in a technical environment and following detailed protocols
• The ability to multitask and produce results under pressure in a dynamic environment
• A high degree of responsibility, reliability, and organization
• Quick learning skills, strong ownership and the ability to get things done

• Direct people-management experience. You will manage a small team in early phases and grow that team across multiple shifts within 18 months.
• Experience in IRB-governed human subjects research

This is a full-time position based in Boston (Charlestown), MA. The role will be hybrid initially while the office is being built out, and is fully onsite once the lab is operational.