Clinical Trials Coordinator Sponsor Dedicated - Prague, Czech Republic

IQVIA is hiring a Clinical Trials Coordinator to provide service to one of our sponsors a well known pharma company with offices in Prague to support the submissions, budgeting, agreement and payments.

Your duties

• Tracking (e.g. essential documents) and reporting (e.g. Safety Reports) 
• Ensure collation and distribution of study tools and documents 
• Update clinical trial databases (CTMS) and trackers 
• Clinical supply & non-clinical supply management, in collaboration with other country roles 
• Manage Labeling requirements and coordinate/sign translation change request 
• Prepare documents and correspondence 
• Collate, distribute/ship, and archive clinical documents 
• Assist with eTMF reconciliation 
• Updating manuals/documents (e.g., patient diaries, instructions) 
• Document proper destruction of clinical supplies. 
• Prepare Investigator trial file binders 
• Execute eTMF Quality Control Plan 
• Obtain translations of documents 
• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions 
• Obtain, track and update study insurance certificates 
• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions. 
• Publish study results for GCTO and RA where required per local legislation 

Your Profile

• Bachelor Degree in Administration or similar field.
• At least 3 -5 years of experience in a clinical environment as a CTA, medical assistant.
• Czech Native and English Proficient Level. Based close to Prague (hybrid role).
• GCP knowledge,
• ETMF, CTMS professional usage. Microsoft Office user.
• Hybrid role.

What you can expect:

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Programs to help you build your therapeutic knowledge
• Excellent working environment in a stabile, international, reputable company
• Attractive benefits package

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com