Real World Late Phase - Clinical Operations Lead Apply locations: Buenos Aires, Argentina / Mexico City, Mexico / Santiago, Chile / Lima, Peru / São Paulo, Brazil Time type: Full time Posted on: Posted 8 days ago Job requisition id: R1376307 Job Overview: Independently direct the execution of the Site & Patient Services (SPS) components of Real World Evidence (RWE) studies by applying clinical research experience and decision making skills to proactively set goals and tangible expectations for SPS project team members. Essential Functions: Oversee the delivery of Site Management project tasks, providing advice and guidance to achieve high performance and quality project deliverables. Ensure overall project efficiency and adherence to project timelines and financial goals; report metrics and out of scope activities. Develop, implement, and maintain the SPS Operations and SPS Risk Management Plan within the agreed project strategy. Manage virtual teams and coordinate start-up processes to achieve SSU completion within the required timelines. Collaborate with the Site Management Team to provide centralized site support, communication, and coordination, to assure accurate and timely completion of all contracted activities. Collaborate with other functional groups within the company such as data management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles. Manage and follow study activities through ongoing tracking and review of study progress. Provide input and report progress to appropriate SPS management and project management leaders. Act as the first line of escalation for site management questions and issues on assigned projects. Lead preparation for in-house audits and in creation of Corrective Action Plans (CAPAs). May participate in business development activities such as proposal development and bid defense. May be assigned additional responsibilities as needed to support projects and other corporate/departmental initiatives. Mentors less experienced Clinical Operational Leads. Minimal Requirements: Bachelor's degree in a health care or other scientific discipline with around 7-4 years clinical research/monitoring experience; or equivalent combination of education, training and experience. Strong written and verbal communication skills including good command of English language. Demonstrated team leadership. In depth knowledge of, and skill in applying clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Skill in understanding and executing complex study designs. Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint. Excellent planning, organizational and problem-solving skills. Ability to manage competing priorities and ensure on-time, high quality delivery of Project. Work Conditions: Home based position Grade 150 - COL Location: looking in the following countries: Argentina, Brazil, Mexico, Chile, Colombia, any city. About Us: IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes. To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us. Similar Jobs (5): Manager, Clinical Operations, Peru - IQVIA Biotech locations Lima, Peru Manager, Clinical Operations, Chile - IQVIA Biotech locations Santiago, Chile J-18808-Ljbffr
