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About the role

Overview: In this role you lead clinical delivery for large, multi-regional studies, partnering with project teams to meet contractual and regulatory requirements. You drive recruitment, risk mitigation, and clinical strategy to achieve study goals while ensuring quality and financial oversight. You work with senior leads to deliver global trials and mentor clinical team members, contributing to proposals and delivery plans. This position sits within IQVIA’s mission to accelerate the development of new treatments and improve patient outcomes. Compensation / Benefits incentive plans health and welfare benefits equal opportunity employer professional development opportunities
Responsibilities: Ensure clinical delivery compliant with ICH-GCP, protocol, contract, SOPs and project plans Meet recruitment targets and implement recruitment strategies Develop and manage project risk mitigation plans throughout the lifecycle Set and develop clinical strategies to achieve project goals Ensure clinical quality delivery and monitor compliance against quality standards Oversee clinical finances (Estimate at Completion) and track changes against baseline Serve as primary Clinical Lead for large, global trials Identify and manage internal and external stakeholders with effective communication Plan resourcing and talent needs; deliver high-quality operational plans and trainings Lead and participate in bid defense preparations and develop Clinical Operation Plans with BD and Project Leadership Mentor and coach new peers; support cross-functional liaison and change initiatives Support site visits and participate in specialized project assignments
Key requirements: Bachelor's degree in health care or a related scientific field 10 years of clinical research/monitoring experience (or equivalent) Deep knowledge of GCP and ICH guidelines Solid understanding of project management concepts Strong IT skills and experience with relevant systems Good knowledge of clinical trial conduct and regulatory requirements (ICH, GCP, local laws) Excellent written and verbal communication in English Problem solving, organizational, prioritization and time-management skills Results-oriented with negotiation and decision-making abilities Leadership, mentoring and training capabilities Proficiency with Microsoft Office (Word, Excel, PowerPoint) Strong communication Problem solving Organization and prioritization GCP/ICH compliance Clinical project management Budgeting and financial oversight (EAC)

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JOB OVERVIEW

Experience level

Manager

Location

Durham, NC

Occupation

Clinical Research Coordinators

Industry

Research and Development in Biotechnology

Posted

today

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