Clinical Trials Regulatory Manager - Durham, United States - IQVIA

Description

Job Description Summary
Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex
Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements.
Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, clinical trial justifications with minimum support of senior staff
May strategically plan and perform European centralized submissions and facilitate global submissions
May provide support on 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.
May perform additional tasks as deemed appropriate by Line Manager

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
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

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.

The potential base pay range for this role, when annualized, is $103, $173, 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.

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward.

Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities.

No matter your role, everyone at IQVIA, including our colleagues at Q2 Solutions, contributes to our shared goal of improving human health.

Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled