Strategic Clinical Operations Lead – Diagnostics Trials

Nanopath; Cambridge (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Nanopath is seeking a Clinical Operations Manager to lead planning, execution, and oversight of clinical studies, including pivotal trials for FDA clearance. This in-person, full-time role combines strategic operations leadership with hands-on execution across study start-up, site initiation, monitoring, and regulatory coordination.

You will own IRB submissions, manage site selection and monitoring, and develop essential study documents to ensure GCP compliance while collaborating with

Qualifications

• Bachelor’s degree in life sciences, nursing, public health, or a related field (advanced degree preferred).
• 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 labs, CROs, and research sites.
• Prior involvement in leading or managing diagnostic/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.

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 core clinical documentation and templates to ensure GCP compliance.
• Track site status, operational milestones, and key deliverables to ensure 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 development of the protocol and preparation of regulatory-facing study materials for IRB submission.

Skills

Project management

Regulatory coordination

Independent work

Communication skills

Attention to detail

Education

Bachelor’s degree in life sciences, nursing, public health, or related field

Advanced degree preferred

Job description

Nanopath is seeking a Clinical Operations Manager to lead planning, execution, and oversight of clinical studies, including pivotal trials for FDA clearance. This in-person, full-time role combines strategic operations leadership with hands-on execution across study start-up, site initiation, monitoring, and regulatory coordination.

You will own IRB submissions, manage site selection and monitoring, and develop essential study documents to ensure GCP compliance while collaborating with