Records and Translation Management Coordinator

Job Duties

• Consolidate stakeholder questionnaires to establish baseline TMF status and identify remediation priorities.
• Perform study-level TMF Inspection Preparation Program (TIPP) reviews, including review of essential document status, quality issue trends, site-level documentation, identified gaps, and TMF metrics.
• Consolidate and summarize TIPP findings into clear readiness updates for presentation to study teams.
• Cook up and coordinate kick-off meetings with clinical study teams and distribute TIPP findings to support Clinical Study Team action planning.
• Track and drive resolution of TMF documentation issues through closure in partnership with Clinical Study Leads, Functional Leads, and CRO contacts.
• Conduct targeted TIPP reviews for supplemental filings, resubmissions, and regional regulatory submissions; provide risk assessments and escalate critical findings as appropriate.
• Provide backend operational support during health authority inspections, including record retrieval, ad hoc report generation, and document package compilation.
• Support Quality Review and oversight activities for vendors from a TMF and Records Management perspective.

Job Requirements

• Demonstrated, deep understanding of the CDISC TMF Reference Model, eTMF systems, and ICH-GCP guidelines.
• Demonstrated ability to prioritize and manage multiple projects simultaneously.
• Excellent communication skills (written and verbal).
• Highly self-motivated, flexible, and able to follow through in an ambiguous, fast-changing environment with a proven ability to meet deadlines under pressure.
• Highly organized and detail-oriented, with the ability to synthesize information and demonstrate strategic thinking.
• Highly proactive, flexible, curious, and resilient.
• Proficient in Microsoft Applications (Word, Excel, Project, and PowerPoint).