Clinical Study Manager – Site Quality & Enrollment

Dm Clinical Research Group; Bay City (MI); On-site; USD 65,000 - 90,000; Full time

Job summary

Dm Clinical Research Group in Bay City, MI seeks a Study Manager I to oversee investigative sites, ensure protocol adherence, and deliver quality data in line with FDA, ICH/GCP guidelines. You will support enrollment targets and coordinate cross-functional teams.

The role requires at least 5 years in clinical research, strong communication, and supervisory abilities; bilingual English/Spanish is a plus. High school diploma with bachelor's preferred; AC RP certification preferred.

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.
• Wide therapeutic range of clinical trials experience preferred.
• Regulatory research experience is a plus.
• ACRP or equivalent certification is preferred.
• Goals-driven while continuously maintaining quality.
• Must be detailed-oriented, proactive, and able to take initiative.
• Must have strong written and communication skills.
• Must have excellent customer service skills.
• Proficient communication and comprehension skills both verbal and written in the English language are required.
• Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.

Responsibilities

• Completing all required training (ICH-GCP, IATA) on a timely basis.
• Maintain knowledge of FDA regulations, ICH-GCP guidelines, SOPs and study protocols.
• Ensure protocol adherence at assigned sites.
• Prepare source documents and investigator site binders.
• Train site teams and support adequate conduct of subject visits and procedures.
• Enforce ALCOA-C standards in trial documentation.
• Monitor data quality, subject retention and timely reporting.
• Collaborate with cross-functional teams to ensure site readiness and enrollment targets.

Skills

Goals-driven

Detail-oriented

Initiative

Strong written/communication

Customer service

English fluency

Bilingual English/Spanish (preferred)

Education

High School Diploma or equivalent

Bachelor's degree

Foreign Medical Graduates

Job description

Dm Clinical Research Group in Bay City, MI seeks a Study Manager I to oversee investigative sites, ensure protocol adherence, and deliver quality data in line with FDA, ICH/GCP guidelines. You will support enrollment targets and coordinate cross-functional teams.

The role requires at least 5 years in clinical research, strong communication, and supervisory abilities; bilingual English/Spanish is a plus. High school diploma with bachelor's preferred; AC RP certification preferred.