Clinical Operations Manager

nanopathinc; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Nanopath is seeking a Clinical Operations Manager to lead planning, start-up, and oversight of multi-site clinical studies, including our pivotal study to support FDA clearance. This is an in‑person, full‑time role driven by GCP standards and regulatory excellence.

You will own IRB submissions, site initiation, monitoring, vendor coordination, and the development of essential documentation to ensure timelines and data quality.

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

Clinical operations

IRB submissions

Site monitoring

GCP compliance

Regulatory coordination

Communication skills

Project management

Education

Bachelor's degree

Job description

Nanopath is developing a first-in-class in vitro diagnostics platform to transform how diseases are diagnosed. We aim to replace lengthy molecular testing workflows by bringing rapid, high-quality diagnostics closer to the patient. Our mission is to improve patient outcomes - starting with women - through a purpose-built platform that delivers actionable results within a single office visit.

The company is headquartered at The Engine, the premier tough technology incubator in the Kendall Square ecosystem. We are collectively committed to health equity and the design of solutions for underserved populations and low-resource settings. Corporate sustainability - both environmental and social - is at the forefront of our decision making.

About the Role

The Clinical Operations Manager will play a critical role in the planning, execution, and oversight of Nanopath's clinical studies. This role combines strategic clinical operations leadership with hands‑on operational execution, supporting study start‑up, site initiation, monitoring, and ongoing study management.

This individual will be joining at an exciting time in Nanopath's trajectory, and will be responsible for our pilot studies as well as our pivotal study in support of FDA clearance.

This is an in‑person, full‑time salaried position .

Key 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 (e.g. case report forms, source documents, and regulatory binders) 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

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

Preferred Experience

• Experience building clinical trial infrastructure and teams at early‑stage companies

Nanopath Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Nanopath does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Nanopath, and Nanopath will not owe any referral or other fees with respect thereto.