RTI International

Compensation

Full Description

About the Hiring Group RTI International, an independent nonprofit research institute dedicated to improving the human condition, is seeking a Lead External Site Manager to support a large, NIH-funded Long COVID clinical trials program. This role will partner closely with the Site Managing Director to oversee external site management activities and support a team of Site Managers across a national network of clinical trial sites. The successful candidate will provide operational leadership, oversight, and hands-on support to ensure high-quality, compliant, and timely execution of site-level activities across multiple protocols. What You'll Do Essential Duties: Program & Site Operations Leadership • Oversee and support external site management functions in collaboration with the Site Managing Director, ensuring consistent execution of site management activities across the portfolio of trials. • Provide day-to-day operational leadership and support for site management team staff, including workload planning/assignments, issue resolution, and implementation of standardized processes. • Support site identification, feasibility/qualification, start-up, activation, maintenance, and close-out activities, with respect to coordination of associated timelines and deliverables. • Serve as an escalation point for external site-related operational challenges and partner accordingly with cross-functional teams to implement effective solutions. Site Contracting & Regulatory Coordination • Support and coordinate external site contracting activities in collaboration with the contracts and finance team, including resolving site-level issues that may impact start up timelines. • Oversee and support site management team staff in the collection, review, and maintenance of essential regulatory documents (e.g., CVs, medical licenses, training documentation, FDA Forms 1572, financial disclosures) from external sites in accordance with protocol, GCP, and NIH requirements. • Partner with regulatory affairs and central IRB teams to help oversee external site IRB submissions, approvals, continuing reviews, and amendments. • Ensure regulatory readiness of external sites prior to activation and throughout trial conduct. Vendor & CRO Oversight • Serve as a primary operational interface with key external vendors supporting site management activities, including CROs or vendors responsible for site monitoring and oversight, patient recruitment, and statistical analysis and data management (e.g., EDC vendor, etc.). • Coordinate closely with monitoring vendors to align site management and monitoring activities, address findings, and support timely issue resolution. • Review and track vendor deliverables related to site performance, monitoring outcomes, and compliance. • Escalate external site- or vendor-related risks and collaborate with internal teams and vendors to implement corrective and preventive actions. • Support vendor onboarding, communication workflows, and ongoing collaboration to ensure efficient integration with site operations and relevant cross-functional teams. Client & Stakeholder Support • Support interactions with NIH program staff and external stakeholders related to site operations, contracting progress, regulatory compliance, and vendor-supported activities. • Contribute to preparation for NIH meetings, reviews, reporting, and audits. • Ensure clear, consistent communication between program leadership, vendors, and participating sites. Quality, Performance & Risk Management • Monitor external site performance metrics, including enrollment, retention, protocol adherence, data quality, and regulatory compliance. • Review monitoring trends and findings in partnership with the site monitoring CRO to readily identify systemic issues. • Support development and implementation of corrective and preventive actions to address both external site- and vendor-related risks. • Promote continuous process improvement and standardization across the site network. Cross-Functional Team Collaboration • Work closely with clinical operations (protocol management), regulatory, central IRB, statistics and data management, technology infrastructure and contracts and finance teams to ensure integrated external site support. • Contribute to development and refinement of SOPs, templates, tools, and training materials related to site management, regulatory compliance, and vendor coordination. • Support onboarding, mentoring, and professional development of site management staff. Programmatic Support • Assist in planning for onboarding of new sites and support for additional protocols as the program evolves. • Provide operational input into resource planning, timelines, and budgeting related to site management, regulatory activities, and other functions supported by external vendors. • Ensure continuity of leadership and coverage in partnership with the Site Managing Director. What You'll Need Required • Bachelor's Degree and 12 years of experience, Master's degree and 10 years of experience, PhD and 6 years of experience, or equivalent combination of education and experience. • Direct experience managing several external sites on IND or regulated clinical trials. • Experience with NIH-funded or government-sponsored trials. • Strong knowledge of GCP and regulatory requirements. • Prior experience as a Lead Site Manager, Lead CRA, or equivalent position title • Ability to work in a matrixed environment. • To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status (e.g., H-1B visa status, etc). Preferred • Familiarity with Long COVID or chronic disease research. • Experience with site performance metrics. • Relevant clinical research certifications (e.g., CCRA, CCRP) are preferred but not required. • Proven experience managing site start-up, enrollment, and follow up for Phase I-IV clinical trials across multiple therapeutic areas. • Knowledge of regulatory requirements (FDA, EMA, ICH-GCP) and experience navigating complex regulatory and ethical processes for clinical trial start-up. • Prior experience managing or leading a team and providing mentorship and training to junior colleagues is highly desired. #LI-KV1 Hiring Salary Range $139,000 - $170,000