Senior Clinical Study Lead & Operations Champion

RTI International; North Carolina; Hybrid; USD 160,000 - 198,000; Full time

Job summary

RTI International is seeking a Lead Clinical Study Manager to oversee multi-site clinical trials, budgets, and cross-functional teams. The role focuses on operational excellence and ensuring trials meet timelines, budgets, and regulatory standards across INDs and CTMs.

The position involves collaboration with project leadership, vendors, and site monitors, with a strong emphasis on quality and compliance in a hybrid work setting.

Qualifications

• Bachelor's Degree and 10 years of experience, or equivalent.
• Clinical research certifications (e.g., CCRA, CCRP) preferred but not required.

Responsibilities

• Lead and oversee all components of clinical trials from protocol to publication.
• Manage cross-functional study teams, identify risks, and mitigate plans.
• Develop and monitor study plans, timelines, and budgets to ensure on-time delivery.

Skills

FDA-regulated trials

Clinical study design

Budget management

Vendor management

Cross-functional leadership

IND experience

GCP/ICH knowledge

Data management awareness

Education

Bachelor's Degree +10 years experience

Clinical research certifications (CCRA/CCRP)

Job description

RTI International is seeking a Lead Clinical Study Manager to oversee multi-site clinical trials, budgets, and cross-functional teams. The role focuses on operational excellence and ensuring trials meet timelines, budgets, and regulatory standards across INDs and CTMs.

The position involves collaboration with project leadership, vendors, and site monitors, with a strong emphasis on quality and compliance in a hybrid work setting.