Clinical Study Manager - Site Leader & Data Quality

Dm Clinical Research Group; Pennsylvania; On-site; USD 90,000 - 130,000; Full time

Job summary

Dm Clinical Research Group, based in Philadelphia, PA, seeks a Study Manager to ensure high-quality clinical research at assigned sites in accordance with sponsor protocols, FDA regulations and ICH/GCP guidelines. You will lead site activities and help achieve sponsor and company enrollment goals on time.

You will manage training, document controls (ALCOA-C), safety reporting, and collaboration with cross-functional teams to ensure study readiness from start through closeout.

Qualifications

• 5+ years of experience in Clinical Research.
• Supervisory experience preferred.
• Regulatory research experience is a plus.
• ACRP or equivalent certification preferred.

Responsibilities

• Train site staff on protocol and GCP requirements.
• Maintain source documents with ALCOA-C standard compliance.
• Oversee site enrollment to meet sponsor and company goals.
• Report adverse events and ensure regulatory documentation is complete.

Skills

Leadership

Communication

Training

Quality focus

Bilingual (EN/ES)

Education

High school diploma or equivalent

Bachelor's degree preferred

Foreign Medical Graduates preferred

Job description

Dm Clinical Research Group, based in Philadelphia, PA, seeks a Study Manager to ensure high-quality clinical research at assigned sites in accordance with sponsor protocols, FDA regulations and ICH/GCP guidelines. You will lead site activities and help achieve sponsor and company enrollment goals on time.

You will manage training, document controls (ALCOA-C), safety reporting, and collaboration with cross-functional teams to ensure study readiness from start through closeout.