Senior TMF Specialist

About this role

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Skills you'll use

What you'll do

• Perform a comprehensive eTMF completeness check/ periodic or milestone review and focus on cross checks, co-dependency checks and identify missing documents in Veeva Vault.
• Ensure eTMF is inspection ready for allocated studies.
• Conduct completeness check and update the expected document list (EDL) as on when required.
• Candidate would have good document knowledge to identify missing documents.
• Perform ALCOEA and metadata check to ensure accuracy and compliance.
• Collaborate with study team and TMF Lead to collect the initial requirements for review.
• Follow-up with study team and close the action items.
• Conduct training for internal team and ensure team queries are addressed.
• Follow standard SLA and deliverables are meet as per agreement with the stakeholders.

Perks & benefits

About ICON plc

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