Country Activation and Submissions Representative
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Job Location:
Monthly Salary:
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
Country Activation & Submissions representative
Portugal
Homebased
Job Overview:
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations standard operating procedures (SOPs) project requirements and contractual/budgetary guidelines. May also include maintenance activities.
Role Scope:
Adaptation of study master ICFs to country/site level
Collection of essential site documents for EC submission and EDP
EC/EU CTR Part II submissions/notifications
Feasibility activities and contract/budget negotiations
Filing tracking and submission of IVD-related documentation
Qualifications and Skills:
B Sc or relevant degree
1 year clinical research experience in submissions
EU CTR experience essential
ICF customization experience
Budget and contract negotiation experience
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 .
At IQVIA we believe that diversity inclusion and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone everywhere. When our talented employees bring their authentic selves and their diverse experiences to work they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.
Required Experience:
Unclear Seniority
Key Skills
- Data Entry
- Deputy
- Drafting
- Hibernate
- Administration Support
- Activex
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
