IQVIA

Clinical Trial Submission Coordinator - Sponsor dedicated - Poland

IQVIA  •  Warsaw, PL (Onsite)  •  20 hours ago
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Job Description

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.

The potential base pay range for this role, when annualized, is zł105,900.00 - zł374,100.00. 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.

IQVIA

About IQVIA

IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific progress, in an effort to advance healthcare. To learn more, visit www.iqvia.com.

Industry
Healthcare & Social Services
Company Size
10,000+ employees
Headquarters
Durham, North Carolina
Year Founded
Unknown
Website
iqvia.com
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