Fulfil the TMF Approver and/or TMF QC Reviewer roles as defined by relevant SOPs
Process, review, and resolve rejected TMF documents for complex studies
Prepare periodic TMF Quality Control checklists for Project Team review
Perform TMF Quality Control to ensure adherence to regulatory and industry best practices
Work with Electronic Document Management and eTMF Systems to review Essential Documents

Minimum 6 months of administrative experience, preferably in the CRO or Pharma industry
Knowledge of working within a highly regulated industry (desirable)
Strong long-term interest in administrative-focused work, with attention to detail
Strong skills in data collection, indexing, and editing
Excellent written and verbal communication skills
Strong interpersonal skills in a fast-paced, deadline-oriented environment
Proficiency in Microsoft Word and Excel

Associate II, TMF Operations

Key skills