Associate Clinical Trials Regulatory Manager - Raleigh, North Carolina, United States of America

Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs, part of our Clinical Trials Regulatory Management department.

RESPONSIBILITIES

• Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer
• Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
• Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications
• May strategically plan and perform European centralized submissions and facilitate global country submissions on complex studies or programs
• May provide support on key regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs)
• Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
• Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).
• Deliver regulatory training/presentations as required, internally or externally
• May mentor junior colleagues and engage in department knowledge sharing
• May perform additional tasks as deemed appropriate by Line Manager

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Good understanding of the regulations, directives and guidance supporting clinical Research and Development
• Demonstrates comprehensive regulatory/technical expertise
• Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
• Strong ownership and oversight skills
• Demonstrated skills in chairing meetings and working on initiatives
• Ability to work on several projects, retaining quality and timelines and can prioritize workload
• Ability to propose revisions to SOPs or suggest process improvements for consideration
• Strong mentoring skills, helping junior colleagues and setting a positive example
• Innovative and solutions-driven
• Strong skills in establishing and maintaining effective working relationships with co-workers, managers and clients
• Strong software and computer skills, including MS Office applications

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9+ years’ experience* (*or combination of education, training and experience)
• EU-CTR knowledge/experience
• Global submissions experience

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

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

The potential base pay range for this role, when annualized, is $103,900.00 - $173,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.