Clinical Study Manager I: Quality & Enrollment Lead

Dm Clinical Research Group; Phoenix (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

Dm Clinical Research Group is looking for a Study Manager to ensure quality research at assigned investigative sites, aligning with sponsor protocols, FDA regulations and ICH/GCP guidelines. The role emphasizes site readiness, enrolment targets, and timely data delivery.

The candidate will train site teams, enforce ALCOA-C standards, oversee adverse event reporting, and coordinate across functions to meet sponsor goals.

Qualifications

• High School Diploma or equivalent required.
• Bachelor's degree preferred.
• Foreign Medical Graduates preferred.
• Minimum of 5 years experience in Clinical Research.
• Supervisory experience preferred.
• Regulatory research experience is a plus.
• ACRP or equivalent certification is preferred.

Responsibilities

• Completing all the DMCR-required training, including ICH-GCP Certification and IATA certifications.
• Maintaining knowledge of FDA regulations, ICH-GCP guidelines, SOPs, guidance documents and study protocol(s).
• Adherence to assigned protocols at their site(s).
• Training site teams and supporting the conduct of study visits and procedures.
• Enforcing ALCOA-C standards with all clinical trial documentation.
• Reporting adverse events to authorities per guidelines.
• Ensuring data quality, subject retention and timely reporting for assigned protocols.
• Collaborating with cross-functional teams to ensure site readiness and sponsor goals.
• Conduct patient consent discussions and explain study protocols clearly to participants.
• Attend Investigator Meetings as required.
• Manage from FPFV to study close-out with adherence to all protocols and manuals.

Skills

Leadership

Regulatory knowledge

Project management

Documentation

Communication

Training

Bilingual English/Spanish

Education

High School Diploma or equivalent

Bachelor's degree

Job description

Dm Clinical Research Group is looking for a Study Manager to ensure quality research at assigned investigative sites, aligning with sponsor protocols, FDA regulations and ICH/GCP guidelines. The role emphasizes site readiness, enrolment targets, and timely data delivery.

The candidate will train site teams, enforce ALCOA-C standards, oversee adverse event reporting, and coordinate across functions to meet sponsor goals.