Hiring: Associate Clinical Lead Director- CAR-T and Cell Gene Therapy Company: IQVIA Location: Durham, NC Job Posted Time: 2026-09-10 15:01:05 Employment Type: Contract Target Skills & Keywords : GCP, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Project Management About the job Experience: •10 years clinical research/monitoring experience or equivalent combination of education, training and experience. Required Skills: •Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans). •Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place. •Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project’s lifecycle. •Work strategically to realize clinical project goals including setting and developing clinical strategies. •Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues. •Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work. •Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials. •Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management. Qualifications: •Bachelor's Degree Health care or other scientific discipline Req •Requires 10 years clinical research/monitoring experience or equivalent combination of education, training and experience. •Requires in-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. •Requires consolidated knowledge of Project Management practices and terminology. •Requires high proficiencies in using systems and technology to achieve work objectives. •Requires good knowledge of project finances. •Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct. •Communication - Strong written and verbal communication skills including good command of English language. •Problem solving - Problem solving skills. •Organization - Planning, time management and prioritization skills. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!