Job Description

Overview

The Clinical Trial Manager (CTM) oversees and supports the daily execution of clinical trials at assigned sites within the BioResearch Partner network. The CTM ensures that all studies are conducted according to protocol, GCP, and company SOPs, while meeting enrollment, retention, and data integrity goals. The CTM acts as a bridge between site coordinators, investigators, and corporate leadership, ensuring high-quality study conduct and operational efficiency.

Key Responsibilities

Supervise Clinical Research Coordinators (CRCs) to ensure protocol adherence, timely data entry, and accurate source documentation.

Oversee patient scheduling, visit conduct, and ensure adherence to recruitment and retention targets.

Conduct ongoing quality reviews to verify data entry is completed within 5 days and all EDC queries are answered within 5 days.

Schedule and prepare for monitoring visits, ensuring findings are minimized and addressed promptly.

Collaborate with investigators to ensure patients meet inclusion/exclusion criteria and are followed throughout the study to reduce screen failures and dropouts.

Review and approve study visit documentation, ensuring ALCOA and GCP compliance.

Track enrollment, retention, and site performance metrics and report weekly to operations management.

Support staff training and ensure protocol updates, deviations, and new versions are communicated effectively.

Liaise with the recruitment department to ensure prescreening and scheduling align with enrollment goals.

Collaborate with regulatory and lab departments to ensure all required documentation, supplies, and safety procedures are in place for study visits.

Qualifications

Bachelor's degree in Health Sciences or related field required.

Minimum +5 years of experience in clinical research, including experience as a Clinical Research Coordinator.

Strong understanding of ICH-GCP, FDA regulations, and clinical trial processes.

Proficiency with RealTime CTMS, EDC systems, and Microsoft Office Suite.

Excellent leadership, communication, and organizational skills.

Performance Metrics (KPIs)

100% of data entry and query resolution completed within 5 days.

?5% screen failure rate and ?5% dropout rate per study.

All monitoring visit findings resolved within 7 business days.

Weekly performance reports submitted on time.

Job Type: Full-time

Pay: $125,000.00 per year

Benefits:

Dental insurance Health insurance Paid time off Vision insurance
Willingness to travel:

50% (Required)
Work Location: Hybrid remote in Newnan, GA 30265