Clinical Operations Coordinator

7 days ago


Chicago, Illinois, United States IQVIA Full time
About the Role

As a key member of our clinical operations team at IQVIA, you will play a critical role in ensuring the smooth execution of clinical trials. Your expertise in vendor management will be instrumental in driving the success of our studies.

Key Responsibilities:
  • Protocol Precision: Review vendor-related sections of the protocol, leveraging vendor expertise to refine specifications and achieve the perfect Final Protocol.
  • Strategic Sourcing: Play a key role in crafting the Study Specification Worksheet (SSW), leading the bid process, and selecting top-notch vendors who align with our vision.
  • Financial Finesse: Oversee the financial aspects with a keen eye, from analyzing quotes/proposals in collaboration with procurement to managing vendor budgets and ensuring accurate invoice reconciliation.
  • Operational Excellence: Provide comprehensive program support by understanding and supplying study demands, ensuring submission documents are complete, and maintaining alignment with site requirements for successful study participation.
  • Dynamic Collaboration: Work in tandem with trial and monitoring teams, procurement, and vendors to ensure a harmonious start-up, resupply, and close-out of studies.
  • Quality Leadership: Uphold service excellence at the study level, acting as an escalation point for queries and ensuring vendors meet our high standards of quality and service.
  • Risk Management Guru: Proactively develop and maintain vendor-related risk maps, complete with contingency plans, and follow up on any risks or issues with precision and care.
  • Innovative Problem-Solving: Drive the analysis of supplier performance issues, identifying trends and implementing corrective actions to continuously improve vendor relations.
  • Process Optimization: Support the implementation and amendment of vendor contracts, standards, templates, tools, and processes, ensuring a streamlined and efficient vendor management system.
  • Technology Integration: Utilize the Unified Vendor Portal (UVP) to manage vendor service delivery, fostering a tech-savvy approach to vendor oversight.
  • Continuous Improvement: Partner with practice leaders on improvement projects, contributing to learning loops and enhancing vendor qualification processes.
  • Educational Development: Collaborate with vendors to develop and refine training materials, ensuring site and monitor readiness through active participation and support.
Requirements:
  • Regulatory Expertise: Deep knowledge of clinical research regulations, including GCP and ICH guidelines, with the ability to apply them in a practical setting.
  • Therapeutic Wisdom: A broad understanding of clinical protocols and therapeutic areas, ensuring meticulous attention to detail in every aspect of the role. Preference for candidates with Oncology Trial experience.
  • Financial Acuity: A strong grasp of project finances, with the ability to manage budgets and control costs effectively.
  • Communication Virtuoso: Outstanding communication skills, both written and verbal, with a flair for engaging and inspiring others.
  • Organizational Mastery: Exceptional organizational skills, with the ability to prioritize tasks and deliver results in a fast-paced environment.
  • Leadership Qualities: Influential leadership skills, including negotiation, decision-making, and the ability to mentor and foster knowledge sharing.
  • Tech Savviness: Proficiency in Microsoft Office and a willingness to embrace new technologies that enhance vendor service delivery.
  • Collaborative Spirit: The ability to forge strong working relationships across diverse teams and cultures, with a commitment to collaboration and innovation.


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