Process study documents in line with client and study requirements, adhering to ICON SOPs/WPs and relevant regulations.
Liaise with study teams and other TMF staff to fulfill responsibilities effectively.
Complete departmental projects as assigned, ensuring adherence to timelines and regulations.
Maintain study files per study/client requirements and ICON SOPs/WPs.
Handle document receipt and processing tasks, including reviewing, scanning, indexing, and archiving.
Provide necessary information for client and departmental status reports as requested.
Inform the Manager of training issues, project activities, quality issues, and timelines.
Participate in audits and document archiving activities as needed.
Assist in training sessions related to your responsibilities.
Address project issues with clients as directed by the Manager.
Undertake special projects or additional duties as requested.

Qualifications:

1-15 years of TMF (Trial Master File) experience with strong knowledge of clinical study documents.
Ability to effectively liaise with study project teams, staff, clients, and management.
Excellent oral and written communication skills.
Bachelor s Degree in Life Sciences preferred.

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