Responsible for coordinating the operational and strategic aspects for Clinical Trial Submissions
Essential Functions:
- Lead the clinical trial submission process from strategy development through to regulatory approval.
- Develop, plan, and coordinate submission strategies to ensure timely and successful trial submissions.
- Facilitate discussions with cross-functional stakeholders, consolidate input, and drive alignment on CTR submission strategies.
- Coordinate and manage submissions through the Clinical Trials Information System (CTIS) portal.
- Perform quality control reviews of CTIS applications and submission packages prior to submission.
- Oversee financial planning, budgeting, and tracking activities related to clinical trial submissions.
Qualifications
- 3 to 5 years of experience preparing and managing Clinical Trial Regulation (CTR) submissions.
- Strong knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable regulatory requirements, with the ability to apply them effectively in a clinical research environment.
- Experience in regulatory affairs and clinical trial submissions.
- Proven project management skills, with the ability to coordinate multiple activities and meet deadlines in a fast-paced environment.
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. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.