Job Overview
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This role involves working with country and regional Clinical Trial Regulatory deliverables, ensuring timely preparation and coordination of submission packs according to applicable requirements.
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Key Responsibilities:
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* Complete regulatory deliverables according to study specifics, ICON policies, procedures, applicable regulations, and ICH-GCP principles.
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* Become involved in staff training and mentoring, contributing to the review of ICON systems and procedures as appropriate.
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* Ensure regulatory deliverables are performed in accordance with relevant regulations, guidelines, policies, and procedures within contractual timelines.
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* Input to strategic planning of submissions to RA, CEC, and other country-level bodies, including risk identification and mitigation.
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* Direct interaction with RA, CEC, and other country-level bodies, tracking and filing central submission/approval progress in CTMS, eTMF, and other applicable systems.
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* Perform translation management according to project requirements, collaborating with other roles in-country/region to meet ICON's deliverables.
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* Adhere to agreed timelines, ensure all project-specific training is completed on time, and identify out-of-scope activities.
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* Support surveillance, collection, and maintenance of accurate clinical trial intelligence.
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Required Skills and Qualifications:
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* Fluent English language skills.
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* Recognition and adherence to ICON's values.
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* Culture of process improvement with a focus on streamlining processes adding value to business and meeting client needs.
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* Strategic planning, risk management, and communication skills.
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* Clinical trials management, regulatory affairs, and compliance experience.
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Benefits:
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This role offers opportunities for professional growth, collaboration with experienced colleagues, and contribution to high-profile projects. Successful candidates will have a strong work ethic, excellent communication skills, and a passion for delivering high-quality results.
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Others:
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This role may involve mentorship of junior team members and contributing to the review of ICON systems and procedures as appropriate.
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