Manager Clinical Trial

Full-time, 40 hours/week

Monday- Friday 8am-4:30pm
Hybrid remote (2-3 days/week onsite)

Summary:

The Clinical Trial Manager provides strategic and operational leadership for the end-to-end management of clinical trials, overseeing operational, financial, regulatory, and systems-related activities from study start-up through closeout. This role is responsible for clinical trial start-up execution, billing compliance, and ongoing fiscal stewardship, including budgeting and financial oversight. The manager leads governance, administration, and optimization of the Clinical Trial Management System (CTMS) while coordinating regulatory affairs and directing regulatory documentation workflows to ensure compliance and efficiency. Serving as a central operational hub, the Clinical Trial Manager aligns business processes, regulatory requirements, and system functionality to support high-quality execution and sustain a high-performing clinical research portfolio

Responsibilities:

1. Lead study feasibility, start-up, budget negotiations, site activation, enrollment tracking, and closeout across the study lifecycle.
2. Coordinate ongoing operational oversight to ensure study milestone achievement.
3. Serve as the primary operational liaison for investigators, sponsors, CROs, and internal stakeholders.
4. Oversee billing compliance activities, including coverage analysis development, budget alignment, and risk mitigation.
5. Monitor and maintain study financials to ensure consistency across contracts, billing plans, and institutional policies.
6. Oversee Advarra OnCore, ensuring accurate CTMS configuration, calendars, and data integrity.
7. Maintain Epic Research Study records and support OnCore-EPIC integration for compliant subject tracking and billing workflows, including oncology trials.
8. Ensure accurate designation of standard-of-care vs. research services, including CPT/HCPCS validation and billing grid alignment.
9. Oversee regulatory submissions and compliance, maintaining audit and inspection readiness throughout the study lifecycle.
   
10. Drive operational excellence through staffing optimization, performance metrics, process improvement, cross-functional communication, and strategic support to research leadership

Other information:

Technical Expertise

1. Demonstrated experience with CTMS platforms and clinical trial budgeting.

2. Excellent analytical, organizational, and communication skills.
3. Provides subject-matter expertise related to clinical research operations, research considerations, and regulatory requirements.
4. Offers clinical insight when reviewing protocols, assessing study feasibility, and troubleshooting operational challenges.
5. Supports the development and refinement of SOPs, workflows, and quality standards supporting research.

Education and Experience

1. Education: Bachelor's degree required; master's degree in a health related, business, or regulatory field preferred
2. Certification: CCRP, CCRC, or CCRA preferred
3. Years of relevant experience: Minimum of five years ofclinical trial managementexperience
4. Years of experience supervising: Minimum of two years of staff supervisory/management experience

5. Knowledge of study start-up, billing compliance, CTMS platforms, and regulatory processes

6. In-depth knowledge of GCP, clinical trial billing regulations, and IRB requirements

Full Time

FTE: 1.000000

Status: Fixed Hybrid