Director, Study Start-Up - IQVIA Biotech

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BASIC FUNCTIONS:

The Director of Study Start-Up is responsible for directing and managing the delivery of all required start-up and operational regulatory activities for the study start-up department. Develop and implement department procedures and directs overall team activities for the component of designated projects in accordance with the scope of work and contracted timelines in line with the portion of the study budget. Assist with the formulation, implementation, and operational integration of strategic and departmental goals and objectives. The Director of Study Start-Up works with the VP of Operations and the Sr. Director Global ISS to prepare forward looking strategy for the Study Start-Up Department as it strives to meet its internal objectives to support overall IQVIA Biotech top and bottom line performance.

KNOWLEDGE, SKILLS & ABILITIES:

• Working knowledge of current clinical trial regulations, globally.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Excellent knowledge of budget management and resourcing
• Considerable working knowledge of medical terminology
• Expert knowledge in study start-up in the clinical trial industry
• Effective communication, organizational, interpersonal, and leadership skills
• Excellent negotiating skills
• Ability to lead and motivate teams
• Excellent presentation skills
• Ability to independently coordinate and manage new processes
• Exceptional ability to conceptualize, develop and manage timelines
• Ability to manage multiple projects and priorities
• Ability to set baseline targets, track trends and implement mitigation plans
• Knowledge of global regulatory processes and issues affecting study start up
• Ability to work independently, prioritize and work with in a matrix team environment is essential
• Ability to work cross functionally to achieve a desired project outcome
• Working knowledge of Word, Excel, and PowerPoint required
• Working knowledge of Study Start-up tracking systems, resourcing systems, and financial management systems preferred
• Ability and willingness to travel.

PHYSICAL REQUIREMENTS:

Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:

• Bachelor's degree (or equivalent), preferred in Healthcare or other scientific discipline and 10 years of clinical trials experience including 6 years' experience in a leadership capacity, at least 3 years in a lead position within Study Start-Up
• Equivalent combination of education, training and experience

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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status