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.

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.

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.

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.

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.