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 •Analyze error trends in documentation and provide feedback, to enable continuous improvement Support study team to ensure document quality requirements are agreed to and met, prior to reporting•Ensure all timelines and quality goals are met; Support study team in addressing/reporting regulatory queries pertaining to document management •Ensure complete TMF is in place at time of study close/submission

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 • Ability to manage conflicting priorities such as performing maintenance tasks and attending to lock activities or timeline tasks that require immediate attention.• Generate, review for accuracy and distribute status reports • Follow up with Study Team in India to ensure that quality and accuracy is consistent and done on schedule.• Implemented streamlined process for Data Clarification Form delivery to sites and Self Evident Correction documentation in database.• Perform User Acceptance Testing For Data Validation and Post Production changes• Draft Sponsor and internal Data Management Meeting Minutes• Reviewing and maintaining study documentation in the eTMF/TMF• Effectively mentor less experienced staff