Associate Reg & Start Up Manager

We currently have an exciting position available for an Associate Reg & Start Up Manager to join our Team. As an Associate RSU Manager you will oversee the execution of Start Up and/or Maintenance for assigned projects in accordance with the agreed RSU strategy and implement and maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy. Other Key responsibilities:

• Ensure collaboration across RSU, including communication with countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
• Assist with creation and/or review of technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Provide overall guidance and oversight of multi-site projects during initial start-up and maintenance phase as an integral member of the study management team.
• 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 execution of the RSU plan.
• Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
• Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required.
• Ensure appropriate quality standards (following RSU Management Plan and relevant Work Instructions) for the duration of Start Up (or Maintenance, as applicable).
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
• Support delivery of presentations/training to clients, colleagues and professional bodies, as required.

Key Requirement:

• Bachelor's degree in life sciences or related field, with 3 years’ relevant experience including demonstrable experience in a regional role or equivalent combination of education, training and experience.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Good understanding of regulated clinical trial environment and knowledge of drug development process
• Ability to exercise independent judgment taking calculated risks when making decisions
• Good leadership skills, with ability to motivate
• Experience in regulatory and/or technical writing
• Ability to work on multiple projects balancing competing priorities
• Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
• Good negotiation and communication skills with ability to challenge
• Excellent interpersonal skills, a strong team player

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.