Description
Parexel is hiring an Initiation Clinical Research Associate II (Site Start Up EUCTR II) in a hybrid capacity in Hyderabad. The role supports complex clinical trial startup activities across European Member States, including EU Clinical Trial Application Part II submissions, CTIS database management, IVDR ethics submissions, regulatory coordination, milestone tracking, document management, and cross-functional collaboration with Clinical Trial Management, Regulatory Affairs, and Clinical Transparency teams. Candidates need a bachelor's degree, 3–6 years of relevant clinical research or trial operations experience, knowledge of ICH-GCP, EUCTR, and IVDR, and experience with CTMS, eTMF, CTIS, EU regulatory submissions, and study startup procedures.
