Stacy Suttle Email & Phone Number

Chapel Hill, Nc, Us

Morrisville, Nc

SME for the file management process and all RM Global department initiatives Provide support and mentor/training to coworkers within RMServe as TMF contact for documentation to Project team, cross functional departments to ensure high quality TMF deliverables are met on time. Follow processes for set up, maintenance, and support for assigned TMF projects.Monitor TMF throughout the study duration, identify and record quality problems, suggest, initiate, recommend or provide solutions as appropriate.Report TMF metrics trending and analysis as appropriate with resolution plans to proactively identify and avoid future issuesFollow applicable SOP’s to ensure completeness & accuracy of TMF Prepare/present TMF related information at internal meetings in a Globally consistent format Provide support and involvement with internal quality or audit process’s as relevantAccountable for delivery of assigned TMF activities in accordance with project requirements and SLA’sManage documentation associated with assigned clinical trialsFollow records management tasks, policies, and proceduresConduct review documents with compliance to Quintiles or customer file plans and SOPsReport TMF health findings at required frequencyAlert Project team and TMF Quality PM to any potential TMF Health issuesProvide regular updates on performance to SLAs

Morrisville, Nc

Manage and provide global support for internal and external users to the Livelink/OpenText Enterprise Content Management (ECM) document management suite. Using a customer oriented approach, manage user support tickets through their life-cycle while working collaboratively with other support functions.Fulfill access requests in accordance with access control requirements.Provide project specific access to eTMF records for approved external customer users and Regulatory auditors.Set up customer eTMF projects in ECM systems using prescribed structure, security and metadata standards.Secure and archive completed customer projects, ensuring project deliverable SLA is achieved.

Morrisville, Nc

eTMF Champion/Subject Matter Expert: Provide training and support for eTMF and regulatory document activities, ensuring training quality and consistency are met. Supported global clinical trial activities close out activities, ensuring electronic project deliverables are submitted to the sponsor in accordance with project requirements and SLA.Report TMF processing and productivity metricsPerform quality reviews on study content metadata to ensure trial documentation is consistent with the Drug Information Association (DIA) Trial Master File Reference Model

Review and maintain TMF for clinical studies which do not have an electronic component. Set up clinical files for new study start-up activities. Participate in customer audits and Regulatory inspection as required. Provide training to clinical project team members on TMF file management and document review process. Maintain and report department metrics to accurately track client service activity, active and closing study activity, and clinical document backlog for monthly project management report.

Contract positionOn-site facilitator for New Hire Orientation (NHO) and Clinical Team Lead (CTL) launches. Prepared training documentation, materials and supplies for on-boarding of newly hired Clinical Research Associates (CRA) and Clinical Project Managers (CPM)Coordinated logistics of 2 day training for 20-25 associates on a bi-weekly basis.Responsible for conducting phone interviews, pre-screening and qualifying candidates for open positions within Quintiles.Areas focused: Clinical Research Associates (CRA), Study Coordinators, Site Managers, Clinical Team Leads, Clinical Trial Managers, Project Managers, Scientists, Business Development Managers.Researched competing companies to identify possible candidates for open positions.Responsible for creating travel itineraries and interview schedules for candidates invited to interview with hiring managers.Prepared CRA Site Visit Reports Performance (5020) reports and distributed the report reminders to Line Managers and CRA's on a weekly basis as part of the CRA performance initiative.