Clinical Study Manager I: Quality & Enrollment

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

Job summary

Dm Clinical Research Group seeks a Study Manager I to oversee quality research at multiple investigative sites in Boston. You will ensure compliance with sponsor protocols, FDA regulations, and ICH/GCP guidelines while driving enrollment to meet sponsor and company goals.

The role requires strong regulatory knowledge, robust documentation, and supervisory experience, with English/Spanish communication as a plus. Join a team dedicated to data integrity and patient safety across trials.

Qualifications

• High School Diploma or equivalent required.
• Bachelor's degree preferred.
• Minimum 5 years experience in Clinical Research.
• Supervisory experience preferred.
• ACRP or equivalent certification is preferred.
• Bi-lingual English/Spanish communication preferred.

Responsibilities

• Ensure quality research at assigned sites in accordance with sponsor protocol, FDA Regulations and ICH/GCP guidelines.
• Maintain current knowledge of FDA regulations, ICH-GCP guidelines, SOPs, guidance documents and protocol(s).
• Train site teams and support conduct of study visits and documentation.
• Enforce ALCOA-C standards in all clinical trial documentation and ensure data quality and subject retention.
• Coordinate with cross-functional teams and sponsor visits to meet enrollment and study goals.

Skills

Clinical Research

Quality Assurance

Regulatory Knowledge

Documentation

Communication

Bilingual EN/ES

Education

High School Diploma

Bachelor's degree preferred

Foreign Medical Graduates preferred

Job description

Dm Clinical Research Group seeks a Study Manager I to oversee quality research at multiple investigative sites in Boston. You will ensure compliance with sponsor protocols, FDA regulations, and ICH/GCP guidelines while driving enrollment to meet sponsor and company goals.

The role requires strong regulatory knowledge, robust documentation, and supervisory experience, with English/Spanish communication as a plus. Join a team dedicated to data integrity and patient safety across trials.