TMF Lead (India)

Allucent

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Clinical OperationsCompany career page

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Role summary

Allucent seeks a TMF Lead to oversee trial master file management for clinical studies, ensuring regulatory compliance and inspection readiness. The role involves coordinating document workflows, quality assurance, and stakeholder communication for small-to-medium biopharmaceutical clients.

What they're looking for

Life science, healthcare, or business degree
Minimum 5 years TMF document filing and quality management experience
Minimum 5 years drug development or clinical research experience
Knowledge of GxP, GDPR, HIPAA, and applicable regulatory requirements
Working knowledge of DIA Reference Model and TMF procedures
Understanding of ALCOA+ standards and good document practices
Strong written and verbal communication skills with fluent English

What you'll be doing

Collect trial requirements and develop study-specific TMF plans with correct setup
Oversee document metadata entry accuracy and consistency with TMF Specialists
Monitor Essential Document Lists and assess TMF completeness regularly
Ensure timely document uploads and conduct quality reviews to identify gaps
Provide status reports to project managers and sponsors on TMF progress

CompensationCompetitive salaries per location

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Date posted5 days ago

Last source checkToday

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