Clinical Research Manager

United-Digestive; Atlanta (GA); On-site; USD 85,000 - 125,000; Full time

Job summary

United Digestive is seeking an experienced Senior Clinical Research Operations Leader to oversee day-to-day multi-site studies, from feasibility to closeout. You will supervise coordinators and staff and drive consistent study execution across sites in alignment with strategic goals.

The role requires strong regulatory knowledge and people leadership. Responsibilities include managing startup, conduct, monitoring, and closeout, tracking enrollment and timelines, and ensuring quality and

Qualifications

• Bachelor's degree in nursing, life sciences, public health, healthcare administration, or related field.
• At least five years of clinical research experience with site management and supervision of staff.
• Experience managing study startup, site activation, conduct, monitoring, and multi-site workflows.
• Knowledge of FDA regulations, ICH-GCP, HIPAA, and IRB requirements.
• Strong project management, people leadership, communication, and organizational skills.
• Master's degree and clinical research certification preferred.

Responsibilities

• Supervise and provide leadership to Clinical Research Coordinators, Research Assistants, and Interns.
• Lead day-to-day multi-site clinical research operations and promote consistent study execution.
• Manage the study lifecycle from feasibility and startup through conduct, monitoring, and closeout.
• Track enrollment, timelines, milestones, compliance, and data quality; escalate risks.
• Serve as operational liaison among investigators, sponsors, CROs, vendors, staff, and centralized support teams.
• Ensure regulatory documentation and study activities meet FDA, ICH-GCP, HIPAA, IRB, sponsor, and organizational requirements.
• Conduct quality reviews, implement SOPs and CAPAs, and maintain audit readiness.
• Recruit, onboard, train, mentor, evaluate, and allocate research staff based on study/site priorities.
• Support research systems, standardized workflows, and practical process improvements across sites.

Skills

Leadership & team management

Regulatory knowledge

Project management

Communication & organization

Education

Bachelor's degree in nursing, life sciences, public health, healthcare administration, or related field

Master's degree in clinical research, healthcare administration, public health, nursing, or related field (preferred)

Tools

Research systems familiarity

Job description

GENERAL SUMMARY OF DUTIES: Leads day-to-day multi-site clinical research operations, staff, and study execution from feasibility through closeout in alignment with the Director's strategy.Exceptional candidates with experience beyond the posted level are encouraged to apply. Based on qualifications, experience, and organizational needs, consideration may be given to placement at a higher level.RESPONSIBILITIES:Duties include but are not limited to:Supervise and provide leadership to Clinical Research Coordinators and Research Assistants/InternsLead day-to-day multi-site clinical research operations and promote consistent, efficient study executionManage the study lifecycle from feasibility and startup through conduct, monitoring, and closeoutTrack enrollment, timelines, milestones, compliance, and data quality; resolve issues and escalate significant risksServe as the operational liaison among investigators, sponsors, CROs, vendors, staff, and centralized support teamsEnsure regulatory documentation and study activities meet FDA, ICH-GCP, HIPAA, IRB, sponsor, and organizational requirementsConduct quality reviews, implement SOPs and CAPAs, and maintain audit and inspection readinessRecruit, onboard, train, mentor, evaluate, and allocate research staff based on study and site prioritiesSupport research systems, standardized workflows, and practical process improvements across sitesEDUCATION, SKILLS, & EXPERIENCE:Required:Bachelor's degree in nursing, life sciences, public health, healthcare administration, or a related fieldAt least five years of clinical research experience, including study coordination or site management and direct supervision of research personnel.Demonstrated experience managing study startup, site activation, conduct, monitoring, closeout, and multi-site operational workflowsKnowledge of FDA regulations, ICH-GCP, HIPAA, and IRB requirements, with strong project management, people-leadership, communication, and organizational skillsPreferred:Master's degree in clinical research, healthcare administration, public health, nursing, or a related fieldClinical research certification and experience with research systems and process improvementWORK ENVIRONMENT:Requires sitting and standing associated with a normal office environment. Travel required as business needs dictate.DRUG FREE WORKPLACE:United Digestive is a drug-free workplace. All offers of employment are contingent upon passing a pre-employment drug screening.EQUAL OPPORTUNITY EMPLOYER:United Digestive is an equal opportunity employer and will not tolerate discrimination in employment on the basis of race, color, age, sex, sexual orientation, gender identity or expression, religion, disability, ethnicity, national origin, marital status, veteran status, genetic information or any other legally protected classification or status.IND123