Lead Clinical Study Manager; Lead CSM​/Clinical Operations Lead

Why RTI

RTI International is an independent, scientific research institute dedicated to improving the human condition. Our vision is to address the world's most critical problems with technical and science-based solutions in pursuit of a better future. Clients rely on us to answer questions that demand an objective and multidisciplinary approach-one that integrates expertise across social, statistical, data, and laboratory sciences, engineering, and other technical disciplines to solve the world's most challenging problems.

We believe in the promise of science and technical solutions, and we push ourselves every day to deliver on that promise for the good of people, communities, and businesses in the US and around the world. If you are looking for the opportunity to make a real difference, RTI is the place for you.

RTI International, an independent nonprofit research institute dedicated to improving the human condition, is seeking a Lead Clinical Study Manager (Lead CSM)/Clinical Operations Lead to join our team. The ideal candidate will be highly motivated, results-oriented, and collaborative with experience leading multi-site clinical trial operations and drug development initiatives.

The Lead CSM will serve as the operational lead for clinical trials, including study planning, budget and resource management, and oversight of project vendors and subcontractors, as applicable. Focused on operational excellence, this person will work closely with Project Leadership to lead a cross-functional study team to ensure the timely conduct of high-quality clinical trials in accordance with study protocols, Good Clinical Practice, Standard Operating Procedures, and applicable regulations.

This is 6-month contract position with potential for extension or transition to regular employment.

The key deliverables for this role are the planning and execution of complex clinical trials in accordance with designated timelines and budgets.

• Independently manages and provides guidance and oversight for all components of clinical trials, from protocol/manual of procedures development and investigational new drug (IND) application submission, through to clinical study report and publication.
• Proactively manages and leads a cross-functional study team, including risk identification and mitigation planning.
• Recommends and implements innovative processes to improve and positively impact clinical trial management and deliverables.
• Performs site and study management and collaborates with data managers, statisticians, regulatory experts, pharmacovigilance team, site monitors, etc.
• Coordinates other vendors involved in the trial such as central lab/biorepository, specialty laboratories, electronic Clinical Outcomes Assessment (eCOA) systems, electronic data capture systems (EDC) and interactive response technology vendor (IRT).
• Acts as a cross functional liaison, communicating trial status and issues, to ensure trial plan aligns with program and client goals. Escalates challenges appropriately to resolve issues related to study protocols or processes.
• Responsible for creating and maintaining timelines, including aligning study start-up, enrollment projections, study conduct, and close-out activities with study and project goals, and using these timelines to track and manage trial progress.
• Responsible for managing trial and vendor budgets, including review of invoices for accuracy.
• Manages clinical site budgets and contracts for assigned clinical trials.
• Works with Project Leadership and partners to identify and assess feasibility of potential clinical trial investigators and sites.
• Develop trial-related training materials for study team members, external team members, and clinical staff. May participate remotely or virtually in site initiation/training visits.
• Responsible for oversight of site monitoring activities.
• Works closely with the study team to develop trial associated clinical forms/data collection tools, including electronic case report forms and user acceptance testing, serious adverse event forms, etc.
• Works with outsourced or in house data management groups to create and implement study-specific tools to ensure clean data, e.g., metrics reports, patient profiles, etc.
• Oversees the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participates in data reviews.
• Responsible for the development of study plans, manuals and study specific documentation including informed…