About this opportunity
Job Overview
Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.
Responsibilities
• Trial and site administration:
o Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
o Ensure collation and distribution of study tools and documents
o Update clinical trial databases (CTMS) and trackers
o Clinical supply & non-clinical supply management, in collaboration with other country roles
o Manage Labeling requirements and coordinate/sign translation change request
• Document management:
o Prepare documents and correspondence
o Collate, distribute/ship, and archive clinical documents
o Assist with eTMF reconciliation o Updating manuals/documents (e.g., patient diaries, instructions)
o Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders
o Execute eTMF Quality Control Plan
o Obtain translations of documents
• Regulatory & Site Start-Up responsibilities:
o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
o Obtain, track and update study insurance certificates
o Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
o Publish study results for GCTO and RA where required per local legislation
• Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:
o Develop country and site budgets (including Split site budget)
o Tracking, and reporting of negotiations
o Maintenance of tracking tools
o Contract development, negotiation, approval and maintenance (e.g. CTRAs) o Update and maintain contract templates (in cooperation with Legal Department)
o Payment calculation and execution (investigators, vendors, grants)
o Ensure compliance with financial procedures
o Monitor and track adherence and disclosures,
o Budget closeout.
Qualifications
• Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree
• Previous experience as a Trainee (Clinical Trials), CTA, or Coordinator is considered an advantage. Minimum 1-2 years in Clinical Research or relevant healthcare experience
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of Czech and English languages.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.
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.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
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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.