Clinical Trials Study Manager I

Dm Clinical Research Group; Brookline (MA); On-site; USD 85,000 - 105,000; Full time

Job summary

Dm Clinical Research Group is seeking a Study Manager I to ensure quality research at assigned sites in Boston/Brookline, MA, in accordance with sponsor protocols and regulatory guidelines. The role focuses on achieving enrollment targets and delivering high-quality data for sponsors.

The position requires overseeing training, SOP adherence, and study documentation while maintaining strong communication with sponsors, IRB, and sites. A 5+ year background in clinical research is preferred.

Qualifications

• High School Diploma or equivalent is required.
• Bachelor's degree preferred for the role.
• Foreign Medical Graduates preferred as an asset.

Responsibilities

• Oversee training to ensure ICH-GCP and SOP compliance.
• Maintain knowledge of FDA regulations, ICH-GCP guidelines, and study protocols.
• Ensure site readiness and adherence to trial documentation (ALCOA-C).
• Train site staff and ensure accurate source documents and data quality.
• Coordinate visits and communications with sponsors, IRBs, and sites.

Skills

Communication skills

English proficiency

Bilingual EN/ES

Education

High School Diploma or equivalent

Bachelor's degree preferred

Foreign Medical Graduates preferred

Job description

Dm Clinical Research Group is seeking a Study Manager I to ensure quality research at assigned sites in Boston/Brookline, MA, in accordance with sponsor protocols and regulatory guidelines. The role focuses on achieving enrollment targets and delivering high-quality data for sponsors.

The position requires overseeing training, SOP adherence, and study documentation while maintaining strong communication with sponsors, IRB, and sites. A 5+ year background in clinical research is preferred.