Clinical Trial Operations Specialist
Job Posting Title- Clinical Trial Operations Specialist (CTOS) Location: Home-based in the U.S. Job Overview Provide operational support and coordination for global clinical trials, ensuring efficient trial execution from planning through close-out. Responsible for managing trial-related documentation, systems, communication, and logistics in compliance with SOPs, ICH-GCP, and regulatory requirements, while meeting quality and timeline objectives. Essential Functions Plan, coordinate, and execute clinical trial activities across regions in compliance with ICH-GCP, ensuring timely and high-quality delivery. Maintain and oversee trial documentation (e.g., ISF, TMF, submissions), ensuring completeness, accuracy, timeliness and audit readiness. Collaborate with global and regional stakeholders, vendors, and trial teams to ensure seamless trial conduct and communication. Manage and maintain clinical trial systems, databases, and tracking tools ensuring data accuracy. Prepare and distribute project plans, status updates, reports, and presentation materials. Monitor trial progress, budgets, and system data, identifying risks and implementing corrective actions as needed. Coordinate documentation workflows, regulatory submissions, and communication with authorities and regional teams. Support reporting, trial close-out activities, and preparation of key deliverables (e.g., CTR appendices). Coordinate logistics for trial meetings, materials, and supplies. Contribute to quality oversight, inspection readiness, and best practices in clinical trial conduct. Act as a key point of contact for trial-related systems, documentation, and operational queries.
Qualifications
University degree qualified and/or comparable professional education with at least 5 years’ experience in clinical trial operations or project coordination. Exceptional communication and stakeholder management skills. Strong knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Excellent organizational and problem-solving skills with ability to work independently, prioritize tasks, and manage projects in a complex international environment. Detail-oriented with strong commitment to quality and compliance. Proficiency in MS Office and clinical trial systems/tools. Fluent in written and spoken English. #LI-Remote #LI-NITINMAHAJAN IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $68,400.00 - $171,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. Apply To This Job