Clinical Study Manager I

Dm Clinical Research Group; Houston (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Dm Clinical Research Group seeks a Study Manager I to oversee clinical operations at assigned investigative sites, ensuring adherence to sponsor protocols, FDA regulations, and ICH-GCP guidelines. You will drive training, monitor enrollment, and maintain essential study documentation.

Responsibilities include ALCOA-C compliance, SAE reporting, data quality, and cross-functional coordination to meet sponsor expectations and timelines.

Qualifications

• High School Diploma or equivalent required.
• Bachelor's degree preferred.
• Minimum of 5 years experience in Clinical Research.
• Supervisory experience preferred.
• Wide therapeutic range of clinical trials experience preferred.
• Regulatory research experience is a plus.
• ACRP or equivalent certification is preferred.
• Proficient English; bilingual (English/Spanish) preferred.

Responsibilities

• Complete required DMCR training, including ICH-GCP and IATA.
• Maintain knowledge of FDA regulations, ICH-GCP, SOPs, and protocols.
• Ensure protocol adherence at assigned sites and training completion.
• Ensure site readiness for sponsor and CRO visits and document actions.
• Train site teams and ensure accurate source documentation.
• Enforce ALCOA-C standards and SAE reporting per guidelines.
• Monitor data quality, subject retention, and timely data reporting.
• Coordinate with cross-functional teams to achieve enrollment goals.

Skills

Detail-oriented

Proactive

Strong communication

Customer service

English proficiency

Bilingual English/Spanish

Education

High School Diploma or equivalent

Bachelor's degree preferred

Foreign Medical Graduates preferred

ACRP certification preferred

Job description

Dm Clinical Research Group seeks a Study Manager I to oversee clinical operations at assigned investigative sites, ensuring adherence to sponsor protocols, FDA regulations, and ICH-GCP guidelines. You will drive training, monitor enrollment, and maintain essential study documentation.

Responsibilities include ALCOA-C compliance, SAE reporting, data quality, and cross-functional coordination to meet sponsor expectations and timelines.