Deborah Marshall Email & Phone Number

• Responsible for implementing and training effective TMF processes
• Oversight for eTMF/TMF review process.
• Generate and analyse overall metrics associated with process.
• Serve as a subject matter expert in TMF Operations, OSIF, eOSIF, SUSARs and study start-up roadmap.
• Training and supporting CTAs in study filing, and archiving.
• Maintaining tracking tools and metric data and communicating compliance metrics with internal and external stakeholders.

London, United Kingdom

• Responsible for implementing and training effective TMF processes across the department.
• Oversight for Quality Control eTMF/TMF review process.
• Generate and analyse overall metrics associated with process.
• Serve as a subject matter expert in TMF Operations, OSIF, EOSIF, SUSARs and study start-up roadmap.
• Perform supervisory duties including, but not limited to, interviewing, hiring, training, developing, performance evaluation, intervention, discipline, and discharge for CTAs.
• Archiving coordination with external off-site storage vendors.

London, United Kingdom

• Maintains an internal standardized filing structure for study related documents; proactively maintains documents within the filing structure, and suggests changes as necessary to maintain organized files.
• Manages the setup and updating of CTMS; maintains knowledge and project expertise for CTMS reporting, study metrics, risk management regarding communication, coordination and eTMF quality.
• Assist the setup of site regulatory binders (site master file including pharmacy file if required).
• Independently uses and develops trial management tools to monitor study activity and perform tasks, including project setup activities Managed the administrative aspects of a number of clinical trials, at every stage.
• Working with protocols (study plans), prepare, distribute, track and file clinical trial documents. Worked with staff at investigator sites.
• Adhering to ICH Good Clinical Practice (GCP) guidelines and working in accordance with Standard Operating Procedures (SOPs).