Job Description

Benefits:

401(k) 401(k) matching Competitive salary Dental insurance Health insurance Paid time off Profit sharing Vision insurance

Regional Manager of Clinical Research

Reports to:

National Director

Location:

Flexible / Remote with travel to research sites nationwide

Employment Type:

Full-Time, Exempt

Position Summary

We are seeking a

Regional Manager of Clinical Research

to oversee and elevate our growing network of clinical research sites. In this key leadership role, you will drive operational excellence, strategic growth, and quality performance across multiple therapeutic areas.



The

Regional Manager of Clinical Research

serves as an operational and clinical research leader responsible for the oversight, strategic growth, and performance of the organization's network of clinical research sites. This role ensures operational excellence, regulatory compliance, and high-quality study execution across all therapeutic areas and enrolment. The Manager will review clinical operations, budgets, SOPs, site performance management, and sponsor/CRO relationships to achieve the organization's business and scientific goals. Additional responsibilities include:



Develop and implement a national strategy for clinical research site operations, aligning with organizational goals and growth objectives. Drive site expansion initiatives, including acquisition, partnership, and start-up of new research centers. Serve as a liaison between senior management, site directors, investigators, and external partners (sponsors, CROs, and IRBs). Ensure adherence to FDA regulations, ICH-GCP guidelines, and all applicable local, state, and federal laws. Oversee internal quality assurance programs, sponsor audits, and regulatory inspections. Develop and maintain quality improvement initiatives, CAPA processes, and compliance training programs. Support proposal development, feasibility assessments, and bid defense meetings. Strengthen and expand relationships with key sponsors and CRO partners to secure new clinical trial opportunities. Represent the organization at industry conferences and networking events to promote visibility and credibility.

Qualifications

Education:

Advanced business or management degree (MBA or MPH) preferred. MD, PhD, PharmD, RN, or advanced degree in life sciences or healthcare will be considered.

Experience:

Minimum 5+ years of progressive leadership experience in clinical research operations, preferably within an SMO, CRO, or multi-site network. Strong understanding of FDA regulations, ICH-GCP, and clinical site management practices. Demonstrated experience leading teams, implementing operational systems, and driving growth. Experience with Phase I-IV clinical trials across multiple therapeutic areas preferred.

Skills and Competencies:

Exceptional leadership, communication, and interpersonal skills. Strategic and analytical thinker with strong business acumen. Proven ability to build and maintain high-level sponsor and investigator and study team relationships. Proficient in clinical trial management systems (CTMS), EDC, and performance analytics tools. Ability to travel up to 50% nationwide.

Compensation and Benefits

Competitive -level salary Comprehensive health coverage Competitive 401(k) with % company match Paid time off and professional development support Travel reimbursement and support resources

About the Organization

Ki Health Partners, LLC,

Site Management Organization (SMO)

division is dedicated to advancing clinical research through operational excellence and patient-centered care. With a growing network of premier clinical sites across the United States, we partner with leading sponsors and CROs to accelerate the delivery of innovative therapies. Our mission is to improve human health by ensuring that every study and sites meets the highest standards of quality, ethics, and scientific rigor.



Flexible work from home options available.