Clinical Operations Manager

Nanopath • Cambridge, MA

10d • Onsite

About The Position

Nanopath is developing an in vitro diagnostics platform intended to bring rapid, high-quality diagnostics closer to patients. The Clinical Operations Manager will plan, execute, and oversee clinical studies, combining strategic leadership with hands-on work across study start-up, site initiation, monitoring, and ongoing study management. The role is responsible for Nanopath’s pilot studies and pivotal study supporting FDA clearance. This is an in-person, full-time salaried position.

Requirements

• Bachelor’s degree in life sciences, nursing, public health, or a related field; an advanced degree is preferred.
• At least 5 years of experience in clinical operations, clinical research, or clinical trial management.
• Demonstrated experience with study start-up, IRB submissions, and site initiation.
• Hands-on experience with site monitoring, on-site and/or remote.
• Strong understanding of GCP, ICH guidelines, and clinical trial regulations.
• Experience working with central laboratories, CROs, and research sites.
• Prior involvement in leading or managing diagnostic or medical device clinical trials.
• Exceptional organizational skills and attention to detail.
• Ability to work independently in a fast-moving, resource-lean environment.
• Excellent written and verbal communication skills.

Nice To Haves

• Experience building clinical trial infrastructure and teams at early-stage companies.
• Advanced degree in life sciences, nursing, public health, or a related field.

Responsibilities

• Lead clinical study start-up and execution for a pivotal, multi-site clinical study.
• Own IRB submissions and ongoing regulatory coordination.
• Manage site selection, qualification, initiation, and monitoring.
• Serve as the primary operational point of contact for clinical sites and reference laboratories.
• Develop and maintain clinical documentation and templates, including case report forms, source documents, and regulatory binders, to support GCP compliance.
• Track site status, operational milestones, and deliverables to support timely study start-up and patient enrollment.
• Coordinate external clinical vendors and support contracting and budget-related communications.
• Track study progress, risks, and milestones, and lead regular status updates with internal stakeholders.
• Support protocol development and preparation of regulatory-facing materials for IRB submission.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager