Country Study Start-Up Expert

Please submit your application in English What You'll Do: Informs the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country level Review/prepare local submission documents and performs submissions (Initial submissions, Substantial Amendments and Notifications etc.) to Ethics Committees (Central...

Please submit your application in English WhatYou'llDo: Support of Regulatory Affairs Study Start-Up (RASSU) department: Informs the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country level Review/prepare local submission documents and performs submissions (Initial submissions, Substantial...

CTI is seeking a Regulatory Affairs Start-Up professional in Milan to support the RASSU department with submissions, country-specific requirements, and document preparation.You will liaise with Ethics Committees, Competent Authorities, and the CTI Legal team to ensure timely, compliant submissions across country sites. Strong Italian and English, plus 1–2...

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. As a Study Start Up Associate II at ICON, you will lead the initiation of clinical trials,...

Fortrea is seeking a Site Start-Up Specialist to coordinate site start-up activities, manage essential documents, and ensure timely regulatory submissions. You will interact with sites, sponsors, and authorities to maintain compliant, audit-ready records.The role requires 2+ years in clinical research or start-up processes, strong ICH/GCP knowledge, and...

At Fortrea , we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist , you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will help bring life-changing treatments to...

DescriptionCountry Study Startup Specialist (PART TIME) - Based in Bucharest - FSPSyneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and...

The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to manage clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.We currently offer the...

Global Study ManagerICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.As a...