Back to Jobs

Clinical Trial Submission Coordinator - Sponsor dedicated - Czech Republic

Prague, Czech Republic | Full time | Home-based | R1564609

Apply Now

Three diverse colleagues smile while collaborating with their devices at a whiteboard.

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.

Where you'll work

Man in a checked shirt works from his clean, light kitchen.

Home-based

You’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.

Smiling man in a dark business suit and light blue tie, posed against a neutral grey studio background.

"I like that we're different. I like that we're a unique organization unlike any other. I like to think of us as the intelligence company for life sciences and healthcare. I do believe there's nothing else like this organization in the world. So if you like something that's different and interesting, you're going to like IQVIA. If you like an organization that has a variety of opportunities, from IT to big data to AI to finance to HR, there are so many opportunities to have an impact."

Jon Deutsch

Senior Director, Enterprise Marketing

"The culture in IQVIA is to be constantly looking at how we can do things better to help our customers, to bring life-changing medicines to patients and also to be a part in designing and developing and implementing these solutions. And so I think it's a great place to join because there is that organizational focus and commitment in driving forward the innovation and just the ability, I think, to work with cross-functional teams who are all excited to be working in these areas. It's a fantastic opportunity."

Natalia Kotchie

Senior Vice President Applied Data Science Center, R&D Solutions

"First of all, we are humans, we have some moments in our lives that are so very important and we need to respect. And something I also always love about IQVIA was that my leaders and people with which I have been working, they always respected a lot as well our personal lives. I never miss a parents' meeting of my kids, and this is something that we shouldn't be giving for granted."

Laura Diaz Ramieriz

Senior Director Global Site Activation

Jon Deutsch

Senior Director, Enterprise Marketing

Culture

Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.

Explore our culture