Alexandra Knoop

• Oversee the execution of Start Up/maintenance for assigned projects • Develop, implement and maintain the Start Up Management Plan in accordance with the Scope of Work and Project Plan within the agreed project plan. • Ensure cooperation across RSU, including communication with regions and countries, to effectively deliver the agreed project scope in compliance with the Start Up Management Plan. • Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory documents

• Prepare and review submission packages for Ethics Committees and Regulatory Authorities (Start-Up and Maintenance activities) according to applicable regulations, standard operating procedures (SOPs) and work instructions • Communicate with Ethics Committees, Regulatory Authorities, Investigative Sites and Sponsors • Act as local Regulatory, Ethics and Contract Expert (Single Point of Contact) in assigned studies

-Act as an SME supporting the management and oversight of TMF activities for paper, electronic and customer TMF systems to ensure delivery of a high quality TMF - SME on all designated Sponsor-specific TMF requirements (e.g. file format, process) - Accountable for delivery of assigned TMF activities in accordance with project requirements & SLA’s - Conduct review of documents with compliance to Quintiles or customer file plans and SOPs