Teams at Worldwide Clinical Trials

Lead QA activities for assigned clinical projects as a GCP subject-matter expert. Perform QA reviews, trend analysis, risk management, investigations, root-cause analysis and CAPA development. Provide audit and inspection support, collaborate with project teams and sponsor QA, and ensure compliance with ICH, FDA, EU and UK GCP requirements. Travel up to 15% as required.

Lead and coordinate cardiometabolic clinical trials from start-up through closeout. Manage technical, financial, and operational aspects, ensure deliverables meet timeline/quality/cost expectations, collaborate with functional leads, and lead multidisciplinary project teams to implement solutions and maintain project performance.

Lead end-to-end proposal development for a CRO: write, edit, coordinate SMEs, manage deadlines, present responses, mentor junior writers, and improve proposal processes while aligning proposals with commercial strategy.