Job Title:
Clinical Trial Regulatory Manager
About the Role:
We are seeking a highly skilled Clinical Trial Regulatory Manager to support complex clinical trial projects and programs.
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.
* Administratively and technically/scientifically reviews core scientific documentation and feedback gap analysis to customers.
* Writes scientific documents such as Investigational Medicinal Product Dossier, clinical trial justifications.
* Strategically plans and performs European centralized submissions and facilitates global country submissions on complex studies or programs.
* Supports key regulatory business development opportunities and completes Data Informed Protocol Assessments (DIPAs).
* Understands the Scope of Work, deliverables and budget for any given project and ensures 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).
* Delivers regulatory training/presentations as required, internally or externally.
* Mentors junior colleagues and engages in department knowledge sharing.
Requirements:
* Good understanding of regulations, directives and guidance supporting clinical Research and Development.
* Demonstrates comprehensive regulatory/technical expertise.
* Good negotiating skills and 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.
Qualifications:
* 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.
* EU-CTR knowledge & experience.
* Global CTA submission experience.
Estimated Salary:
$80,000 - $110,000 per year.
About Us:
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.