# Clinical Trial Submissions Coordinator

**Company**: IQVIA
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Budapest-Hungary/Clinical-Trial-Submission-Coordinator---Sponsor-dedicated---Hungary_R1564619?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_c020bbe7-ab5

## Description

We are seeking a Clinical Trial Submissions Coordinator to lead the clinical trial submission process from strategy development through to regulatory approval.

**Key Responsibilities:**

- Develop and implement submission strategies to ensure timely and successful trial submissions

- Facilitate discussions with cross-functional stakeholders to 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

**Requirements:**

- 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

- 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

## Skills

### Required
- Good Clinical Practice (GCP)
- International Council for Harmonisation (ICH) guidelines
- regulatory affairs
- clinical trial submissions
- project management
- CTIS portal

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Budapest-Hungary/Clinical-Trial-Submission-Coordinator---Sponsor-dedicated---Hungary_R1564619?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)