Manager Clinical Research Business and Regulatory Operations

Full-time, 40 hours/week
Monday- Friday 8am-5pm

Hybrid remote, 3 days/week onsite

Summary:

The Manager, Clinical Research Business & Regulatory Operations provides strategic and operational leadership across the financial, regulatory, and systems infrastructure that supports clinical research. This role oversees clinical trial budgeting and fiscal stewardship, manages the Clinical Trial Management System (CTMS) governance and optimization, and directs regulatory documentation workflows to ensure compliance, efficiency, and high-quality execution of research activities. The manager serves as a central operational hub, aligning business processes, regulatory standards, and system functionality to support a high performing clinical research portfolio.

Responsibilities:

1. Lead development, negotiation, and management of clinical trial budgets, financial tracking, and variance analysis.
2. Monitor revenue, expenses, and contract alignment to ensure fiscal accuracy and financial sustainability.
3. Oversee CTMS administration, configuration, optimization, and integration with financial and regulatory workflows.
4. Develop and enforce CTMS governance standards, data quality processes, and user training programs.
5. Direct regulatory documentation workflows, ensuring highquality preparation, submission, and maintenance of essential documents.
6. Ensure compliance with federal regulations, ICH GCP, institutional policies, and sponsor requirements.
7. Manage IRB submissions, amendments, continuing reviews, safety reporting, and document control processes.
8. Lead crossfunctional coordination between clinical operations, regulatory teams, finance, investigators, and leadership.
9. Drive process improvement initiatives and develop SOPs, work instructions, and training materials.
10. Promote quality, compliance, audit readiness, and operational transparency by monitoring KPIs and guiding corrective actions.

Other information:

Technical Expertise

1. Demonstrated experience with CTMS platforms (preferably ENCOR) and clinical trial budgeting.
2. Strong knowledge of GCP, FDA regulations, and institutional research requirements.
3. Leadership experience with the ability to supervise, mentor, and develop staff.
4. Excellent analytical, organizational, and communication skills.

Education and Experience

1. Education Bachelor of Science, healthcare, finance or related field or 10 years relevant experience, Master's degree preferred.
2. Licensure: NA
3. Certification: NA
4. Years of relevant experience: minimum 5 years of experience in clinical research operations, regulatory affairs, research finance, or related areas.
5. Years of supervisory experience Minimum 2 years

Full Time

FTE: 1.000000

Status: Fixed Hybrid