Jane Henry Email & Phone Number

North Wales, PA

• Responsible for ensuring a complete and accurate Trial Master File through documentation quality and consistency across programs
• Determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress
• Assess impact of potential changes to TMF specifications prior to implementation; collaborate with CPM if modifications are necessary
• Review audit reports and document metrics for trends and to ensure that program document management deliverables are on target
• Support the preparation of appropriate audit responses
• Serve as point of contact for providing responses to regulatory authorities with regard to documentation management activities for audits, regulatory submission issues, and product defense

North Wales, PA

• Data Validation of system generated discrepancies
• Manual creation of discrepancies based on manual review of ad hoc or programmed listings
• Query resolution based on site responses to Data Clarification Forms
• Communicate directly with Clinical staff (CRAs, CTAs, CPMs) to troubleshoot site resolution of issue(s) and/or query resolution of complex nature
• Evaluating data for site trends and notification of trends to Clinical team
• Develop and generate ad hoc reports and listings