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Regulatory Manager for Clinical Trials
2 semanas atrás
About the Role
We are seeking a highly skilled Regulatory Manager for Clinical Trials to join our team at IQVIA LLC. As a key member of our regulatory management group, you will be responsible for overseeing complex clinical trial projects or programs.
Key Responsibilities
- Act 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 such as Investigational Medicinal Product Dossiers and 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.
Requirements
- 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 a 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.
Work Environment
The ideal candidate will have a strong background in clinical research and development, with a proven track record of successfully managing complex clinical trials.
