At IQVIA Biotech, we partner with visionary biotech companies to transform innovation into patient impact. With dedicated teams, deep therapeutic expertise, and a biotech tailored delivery model, we accelerate clinical development from early phase through global registrational studies.Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.Collaborate and liaise with study team members for project execution support as appropriate.RequirementsExperience of independent on-site monitoring of Oncology therapeutic area for unblinded studies.In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesLife science degree educated or equivalent industry experienceFlexibility to travel to sites as required*Please note - this role is not eligible for visa sponsorship*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 IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. 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. SummaryLocation: Reading, Berkshire, United KingdomType: Full time
Medical Research Associate in Reading employer: IQVIA
IQVIA in Livingston, Scotland is an excellent employer that fosters a collaborative team environment and prioritises employee growth through outstanding career development opportunities. Working as a Lab Operations Assistant here not only allows you to contribute to meaningful projects but also ensures you are part of a supportive workplace that values safety and professionalism.
