Project Specialist - USA

Job description

About the Role Project Specialist (PS) works collaboratively with the Project Manager (PM) to support project management activities in accordance with local regulation, ICH GCP guidelines, Novotech/client SOPs and the Project Agreement to deliver the project on time and to budget. PS also works in partnership with the PM to mitigate risk and ensure customer satisfaction related to assigned projects. Project Specialist should liaise with the Clinical teams and assist the PM for the delivery of the project from start up through to the Close out phase. Project Specialist is expected to have a sound understanding of the drug development and clinical trial process, ICH GCP, international and local regulatory requirements. Responsibilities: - Assist the PMs to manage project deliverables, cost control, and risk management activities. - Ensure set up and ongoing maintenance of operational project plans, timelines and study tracking tools and systems (such as CTMS, eTMF and Financial Force), as required. - Take a lead role to provide support services to the team on regional studies while coordinating with the regional Clinical Support teams. - Prepare study templates and share with project...