This role will provide help with the data review exercise in support of an upcoming database lock Key Responsibilities: Review of detailed clinical study data for two pivotal UC Ph 3 trials during ongoing data cleaning initiative Look for potential missed AEs Ensuring consistency between clinical significance and potential AEs Confirming inclusion/exclusion eligibility Consistency between...

We are currently seeking a Project Manager consultant (PM) experienced in Pharmaceutical Drug Product Development with direct experience working on submission timelines and regulatory teams. She/he will serve as a PM supporting the lead Regulatory PM. The primary responsibility will be to provide project management expertise and support to core- and module sub- teams, ensuring that the project...