Senior Clinical Trial Lead - Cardiovascular and Metabolic

Regulatory Jobs; Boulder (CO); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Health benefits

Discretionary bonus plan

Stock option grants

Stock purchase plan

401(k) with match

Paid time off

Job summary

Edgewise is headquartered in Boulder, Colorado and offers an on-site (preferred) or remote role for its growing Clinical Operations team. You will oversee complex, high-risk studies, including vendor management and site activation, ensuring alignment with the program strategy.

The role requires extensive experience in clinical operations, regulatory knowledge, and cross-functional collaboration, with salary in the stated range.

Qualifications

• 7+ years of clinical operations experience in clinical trial design and conduct.
• Experience with GCP, FDA regulations, and ICH guidelines.
• Experience across multiple therapeutic areas and global studies.

Responsibilities

• Provide operational expertise and strategic input for assigned clinical studies.
• Manage study budgets including site payments and vendor invoicing.
• Lead feasibility/site selection with insights to align study plans with program strategy.

Skills

Project management

Communication

Regulatory knowledge

Education

Bachelor's degree in nursing, scientific or business-related field

Tools

Electronic Data Capture (EDC) systems

Clinical Trial Management Systems (CTMS)

Job description

Edgewise is headquartered in Boulder, Colorado and offers an on-site (preferred) or remote role for its growing Clinical Operations team. You will oversee complex, high-risk studies, including vendor management and site activation, ensuring alignment with the program strategy.

The role requires extensive experience in clinical operations, regulatory knowledge, and cross-functional collaboration, with salary in the stated range.