JobMesh

Clinical Research Associate - IQVIA BIOTECH (homebased in Paris)

IQVIA · Paris, Île-De-France, FR

At IQVIA Biotech, we partner with visionary biotech companies to transform innovation into patent impact. With dedicated teams, deep therapeutic expertise, a...

Job description

At IQVIA Biotech, we partner with visionary biotech companies to transform innovation into patent impact. With dedicated teams, deep therapeutic expertise, and a biotech tailored model, we accelerate clinical development from early phase through global registrational studies. The successful candidate must be based in a commutable distance to Paris. Responsibilities: - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. - 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 app...