SMA I
About the role
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- Ability to work on study teams that are often virtual, multi-cultural, and multi-disciplinary
- Serves as the primary contact for sites and investigators participating in studies
- Acts as a resource for internal study teams and other ICON departments
- Maintains, reviews, and ensures adequacy of information and data contained in site management reports, tracking systems (CTMS or others) and other site management documents
- Conducts and completes remote site management activities, with support as needed, according to applicable SOPs and the Site Management Plan
- Participates in QA audits as needed
- Regularly attends and contributes to project specific and departmental meetings
- Ability and willingness to travel as needed (drive and fly) – approximately 25% of the time
- Reviews drug storage and drug accountability procedures (as applicable), in accordance with applicable SOPs
- Maintains and archives study documentation and correspondence, as needed
- Assists with site contracting process, as needed
- Assists with timely preparation and submission of regulatory documents for IRB/IEC submissions according to local requirements, with support, as needed
- With support, demonstrates the ability to manage site assignments and workload
- Maintains Sponsor and patient confidentiality
- Actively participates in regular meetings with Project Managers or delegate, and/or RS Lead
- Assists in development of site and patient enrolment strategies with project team; works to motivate sites to meet enrolment timelines
- Developing knowledge of and compliance with local regulatory requirements
- Compliant and current with departmental and corporate policies and procedures
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. See all locations Learn more about Our Culture at ICON
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