Your responsibilities include, but are not limited to:
May lead studies in maintenance or in closeout phase or ongoing studies post primary database lock with the oversight of the LCTL/CTL, as assigned. Support the clinical protocol development process in collaboration with the CTL/Lead CTL and the Clinical program Leader (CPL): chip in to the development of clinical protocols, amendments and related documents; drive and/or supprt trial-related documents and processes.
development of clinical section of regulatory documents like Investigator’s Brochure, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
support the global multidisciplinary CTT to ensure all trial results are met according to timelines, budget, quality standards and operational procedures: attend CTT meetings, assist in report study progress and issues.
support the CTL/Lead CTL, in the ongoing review and cleaning of the clinical trial data, support final analysis and...