Oeiras, Portugal | Full time | Home-based | R
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.