Clinical Trial Submission Coordinator - Sponsor dedicated - Poland

IQVIA LLC; Warszawa; On-site; PLN 106,000 - 374,000; Full time

Job summary

IQVIA LLC is seeking a seasoned professional to coordinate operational and strategic aspects for Clinical Trial Submissions in Warsaw, Poland. The role covers strategy development, submission planning, and regulatory approval processes, ensuring timely and successful trial submissions.

You will lead discussions with cross-functional teams, manage CTIS submissions, and perform quality control on submission packages.

Qualifications

• 3 to 5 years of experience preparing and managing Clinical Trial Regulation (CTR) submissions.
• Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
• Experience in regulatory affairs and clinical trial submissions.
• Proven project management skills, coordinating multiple activities and meeting deadlines in a fast-paced environment.

Responsibilities

• Lead the clinical trial submission process from strategy development through regulatory approval.
• Develop and coordinate submission strategies to ensure timely and successful trial submissions.
• Facilitate discussions with cross-functional stakeholders and drive alignment on CTR submission approaches.
• Coordinate and manage submissions through the 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.

Skills

Regulatory submissions

Project management

Stakeholder coordination

Tools

CTIS Portal

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 is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments.

Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.