Regulatory and Start Up Coordinator

At IQVIA, 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. In your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and, ultimately, improve outcomes for patients.

This is an exciting Job opportunity for a Regulatory and Start up Coordinator within the Country Site Activation team. You would be required to perform tasks at a country level pertaining to Site Activation (SA). These are to be performed in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. These may also include maintenance activities.

You will have dedicated support to develop the career of your choice. In fact, you will be building a smart and flexible career with no limit. You can start your career in clinical research being Start up coordinator.


Job Responsibilities:

• Under direct supervision you will need to perform site activation activities in assigned studies for investigative sites, according to applicable regulations, SOPs, and work instructions; RA/EC submissions, maintenance activities.
• Customization and collections of regulatory & essential documents, IP pack review and contacting sites etc.
• Track and follow up the progress of the approval and execution of regulatory documents – contractual documents, Informed Consent Form (ICF) and other Investigational Product (IP) release documents.
• Work towards updating and maintenance of internal systems, databases, tracking tools, timelines, and project plans with accurate and complete project specific information.
• Working closely with the Site Activation Manager (SAM), Project Management team, site staff and other departments as necessary.
Qualifications:
• 1 - 3 years’ experience in an administrative/customer centric work environment.
• Fresh Graduate can apply.
• English - Advanced (C1) and Slovak - Proficiency (C2)