Clinical Operations Manager

The role

The Clinical Operations Manager will lead the planning, execution, and oversight of clinical studies. This includes supporting study start-up, site initiation, monitoring, and ongoing study management for pilot and pivotal studies.

What you will do

• 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
• Coordinate external clinical vendors and support contracting and budget-related communications
• Track study progress, risks, and milestones
• Support development of the protocol and preparation of regulatory-facing study materials for IRB submission

Required qualifications

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

Nice to have

• advanced degree
• Experience building clinical trial infrastructure and teams at early-stage companies

About the company

Nanopath is developing a first-in-class in vitro diagnostics platform to transform how diseases are diagnosed. The company is headquartered at The Engine in the Kendall Square ecosystem.