Sr Study Start Up Associate
About the role
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* Perform feasibility , site-identification ,site contract negotiation, and other study start up activities assigned
* ·Provide country specific Study Start Up expertise to Study Stan Up Team Leads and project teams.
* Responsible for the preparation and coordination of submissions to regulatory, ethics and other bodies
* 'Develop, finalize and review Master and Country Specific Subject Information Sheet and Informed Consent Forms.
* Review and translate Drug labels
* 'Perform independent quality review of submission packages
* Perform timely and accurate data entry of all relevant Study Stan Up activities into the appropriate clinical trial management system
* Responsible for the timely follow-up of queries made by EC/CA
* Responsible for the collection of critical documents required for IP Release
* Responsible for the budget,negotiation execution and tracking of contract with sites.
*·Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee EC submission information and similar information for other related organizations,for the assigned countries.
*·To be familiar with ICH-GCP, and relevant country regulations/guidelines and ICON SOPs
* Perform regulatory document maintenance,amendments periodic updates and safety letters,where applicable
* Develop end maintain effective relationships with local,regional and country authorities
Role Requirements
- Bachelor's Degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline
- Global clinical trials experience with awareness of global regulatory requirements for clinical site initiation documents
- Proven experience handling study start ups for more than 2+ years
ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.
EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin
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. Learn more about Our Culture at ICON
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