Clinical Study Lead - Site Start-Up & Execution

Artech Information System LLC; United States; Remote; USD 100,000 - 160,000; Full time

Job summary

Artech Information System LLC seeks an experienced Study Manager to drive site start-up, maintenance and close-out, ensuring patient safety and data quality. You will work with clinical operations teams, sponsors, and CROs to resolve site issues and achieve enrollment readiness.

The role requires on-site monitoring at times, candid collaboration across stakeholders, and willingness to travel up to 50% to support multiple sites. Strong knowledge of FDA regulations and GCPs is essential.

Qualifications

• Bachelor’s Degree in Life Science required.
• Minimum 5 years of study management experience, preferably in Rare Diseases.
• Experience in on-site monitoring of clinical trials.
• Knowledge of FDA regulations and GCPs.

Responsibilities

• Remove obstacles to site start-up, maintenance and close-out while engaging site staff.
• Identify and interpret problems, drive resolution and influence changes.
• Liaise with site, sponsor and CRO to resolve issues and initiate sites.
• Escalate clinically identified site issues to PM or designee.
• Support the management of multiple academic sites with coordination and support.
• Protect the rights, safety and data integrity of subjects.

Skills

Problem solving

Site management

Regulatory knowledge

Communication skills

Travel readiness

Education

Bachelor's Degree in Life Science

BS/MS

Job description

Artech Information System LLC seeks an experienced Study Manager to drive site start-up, maintenance and close-out, ensuring patient safety and data quality. You will work with clinical operations teams, sponsors, and CROs to resolve site issues and achieve enrollment readiness.

The role requires on-site monitoring at times, candid collaboration across stakeholders, and willingness to travel up to 50% to support multiple sites. Strong knowledge of FDA regulations and GCPs is essential.