探索更有意义的职业

IQVIA is hiring a Clinical Trials Coordinator to provide service to one of our sponsors a well known pharma company with offices in Brussels 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 1 year of experience in a clinical environment as a CTA, medical assistant.
• French and Dutch and English Proficient Level. Belgium Based.
• 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