Clinical Trial Submission Coordinator - Sponsor dedicated - Hungary
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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.
Job details
How this role compares
Computed from every other active Clinical Development role in our database, not just this employer's listings.
We currently track 1275 comparable Clinical Development roles across 107 biopharma companies.
Salary context
406 of 1275 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1275 comparable roles
+ 48 more countries
Seniority mix
903 of 1275 peers have a known seniority level
Therapeutic area mix
189 of 1275 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.