Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.
Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.
Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
Maintaining accurate and up-to-date records of regulatory submissions and approvals.
Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.
Participating in study start-up meetings and providing input on regulatory requirements and timelines.
Your profile
Bachelor's degree in life sciences or a related field.
Previous experience in clinical research or regulatory affairs preferred, but not required.
Strong attention to detail and organizational skills.
Advanced English
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.
#LI-DG1 #LI-Hibryd What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click to apply Share: ICON and you Impactful work. Meaningful careers. Quality rewards. At ICON, our employees are our greatest strength. That's why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. List #1 Day in the life Similar jobs at ICON Salary Location India, Chennai Location Mexico City Sofia Warsaw Johannesburg Bangalore Chennai Bengaluru Minsk Tbilisi Remote Working Office Based Business Area ICON Full Service & Corporate Support Job Categories Study Start Up Job Type Permanent Description We are currently seeking a Director, FSA (Feasibility Site Activation) to join our global leadership team. This position will be based in India and will play a key role in shaping and leading centrali Reference JR135146 Expiry date 01/01/0001 Author Author Salary Location Poland, Warsaw Location Sofia Warsaw Tbilisi Remote Working Office or Home Business Area ICON Full Service & Corporate Support Job Categories Study Start Up Job Type Permanent Description Role Summary:Prepare, review, approve, process and track Subject Information Sheets (SIS) and Informed Consent Forms (ICF) required for study site activation and study conduct in accordance with ICON Reference JR133525 Expiry date 01/01/0001 Author Author Salary Location Bulgaria, Sofia Location Sofia Budapest Bucharest Remote Working Office or Home Business Area ICON Full Service & Corporate Support Job Categories Study Start Up Job Type Permanent Description 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 Reference JR136996 Expiry date 01/01/0001 Author Author Salary Location Hong Kong, Hong Kong Location Hong Kong Remote Working Office Based Business Area ICON Full Service & Corporate Support Job Categories Study Start Up Job Type Permanent Description TBC Reference JR133633 Expiry date 01/01/0001 Author Author Salary Location Taiwan, Taipei Location Taipei Remote Working Office or Home Business Area ICON Full Service & Corporate Support Job Categories Study Start Up Job Type Permanent Description At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It Reference JR136924 Expiry date 01/01/0001 Author Author Salary Location Taiwan, Taipei Location Taipei Remote Working Office Based Business Area ICON Full Service & Corporate Support Job Categories Study Start Up Job Type Permanent Description We are currently seeking a Study Support Assistant to join our diverse and dynamic team. As a Study Support Assistant at ICON, you will play a pivotal role in providing administrative and operational