Senior Clinical Study Lead - Global Trials Operations

RTI International; Few (NC); Hybrid; USD 160,000 - 198,000; Part time

Job summary

RTI International, a trusted independent nonprofit research institute in the United States, seeks a Lead Clinical Study Manager to oversee multi-site clinical trials and drug development initiatives. The role combines study planning, budget oversight, and vendor management to ensure timely, high-quality trials in compliance with GCP and regulatory requirements.

The position is a 6-month contract with potential extension or transition to permanent employment, based on project needs and

Qualifications

• Must have FDA-regulated clinical trial experience and knowledge of trial design, planning and monitoring.
• 4+ years in FDA-regulated trials, including CRA/field monitor exposure; sponsor experience a plus.
• Experience in planning, launching, monitoring, and closeout of Phase 1–3 trials.
• Familiar with CFR, ICH, GCP and GDPR data privacy requirements.
• Proficient with CTMS, data management systems, TMF and CRO/vendor oversight.
• Able to review performance metrics, drive improvements, and present findings.
• Strong communication and presentation skills; collaborates across teams and vendors.

Responsibilities

• Plan and execute complex clinical trials within timelines and budgets.
• Lead a cross-functional study team; identify risks and mitigation strategies.
• Develop and implement processes to improve trial management efficiency.
• Coordinate site monitoring, data management, regulatory, and vendor activities.
• Oversee timelines, enrollment projections, and study close-out activities.
• Manage trial and vendor budgets and contract oversight.

Skills

FDA-regulated trials

Cross-functional leadership

Project management

Clinical study planning

Regulatory compliance

CTMS familiarity

Data-driven decisions

Problem solving

Effective presentations

Communication skills

MS Office & collaboration tools

Education

Bachelor’s degree + 10 years

Master’s degree + 8 years

PhD + 6 years

Clinical research certifications (CCRA/CCRP) preferred

Tools

MS Office Suite

SharePoint

MS Project

Smartsheet

EDC systems

eCOA systems

TMF tools

Job description

RTI International, a trusted independent nonprofit research institute in the United States, seeks a Lead Clinical Study Manager to oversee multi-site clinical trials and drug development initiatives. The role combines study planning, budget oversight, and vendor management to ensure timely, high-quality trials in compliance with GCP and regulatory requirements.

The position is a 6-month contract with potential extension or transition to permanent employment, based on project needs and