Clinical Study Lead I

Dm Clinical Research Group; Monitor Charter Township (MI); On-site; USD 90,000 - 120,000; Full time

Job summary

Dm Clinical Research Group is seeking a Study Manager I to ensure quality research at assigned investigative sites in line with sponsor protocols, FDA regulations and ICH/GCP guidelines. The role focuses on enrollment targets, data quality and timely reporting across multiple sites.

You will train site staff, oversee visits, enforce ALCOA-C documentation standards, and collaborate with cross-functional teams to achieve sponsor goals and study milestones.

Qualifications

• Minimum 5 years experience in Clinical Research
• Supervisory experience preferred
• Regulatory knowledge a plus
• Knowledge of FDA regulations and ICH-GCP guidelines

Responsibilities

• Ensure study enrollment meets or exceeds sponsor expectations and company goals
• Train site teams and support adequate conduct of visits and procedures
• Enforce ALCOA-C standards in trial documentation
• Ensure adverse events and safety reporting to authorities per guidelines
• Maintain data quality, subject retention and timely reporting for assigned protocols
• Collaborate with cross-functional teams to ensure start readiness before FPFV

Skills

Communication skills

Written communication

Customer service

Bi-lingual English/Spanish

Education

High School Diploma or equivalent

Bachelor’s degree preferred

ACRP certification preferred

Job description

Dm Clinical Research Group is seeking a Study Manager I to ensure quality research at assigned investigative sites in line with sponsor protocols, FDA regulations and ICH/GCP guidelines. The role focuses on enrollment targets, data quality and timely reporting across multiple sites.

You will train site staff, oversee visits, enforce ALCOA-C documentation standards, and collaborate with cross-functional teams to achieve sponsor goals and study milestones.