• Oversee the execution of Start Up (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU strategy, adhering to project timelines.
• Develop, implement and maintain the RSU Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
• Create and/or review technical and administrative documentation to support business development and enable study initiation, as required.
• Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation of clinical trials, whilst enabling compliance with regulatory requirements.
• Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the SAMP.
• Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies, as required.
• Execute operational strategy/ expectations for clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
• Work with Quality Management to ensure appropriate quality standards for the duration Start Up.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com