Valerina Metodieva

• Implemented quality control measures; improved accuracy in data recording.
• Managed data collection for effective documentation of clinical trials.
• Coordinated logistics to facilitate smooth functioning of clinical trials.
• Coordinated trial activities to ensure compliance with regulations.
• Prepared progress reports to maintain transparency throughout the trial phase.
• Developed analytics tools to track project progress and impact.
• Collaborated with cross-functional teams to draft strategic, realistic project schedules and plans.
• Improved operations by generating project status reports and identifying issues for corrective action.
• Oversaw risk assessments throughout project lifecycle, effectively mitigating potential issues.
• Created digital file classification system for company-wide use.
• Drafted procedural statements and guidelines for company-wide use.
• Created classification systems to manage archives.
• Successfully delivered on tasks within tight deadlines.
• Completed duties to deliver on targets with accuracy and efficiency.
• Used critical thinking to break down problems, evaluate solutions and make decisions.
• Used Microsoft Word and other software tools to create documents and clear communications.

Responsibilities:

• Support Clinical Operations in the execution and delivery of studies
• Provide administrative support to the project team and CMO as assigned
• Provide support from trials start-up through trials close-out
• Follow established SOPs, ICH-GCP, and other applicable regulatory requirements across all tasks
• Ensure all training requirements are documented appropriately and required certification is filed
• Facilitate in both internal and external audits/inspections as required
• Manage documentation associated with clinical trials, both in paper and electronic format in accordance with regulations and timelines
• Set-up and management of Trial Master File (TMF) system
• Merging of TMF from vendors upon trial closure and quality control documents
• · Review SOP/procedures for relevant tasks
• Draft and/or assist with the preparation of trial-related documents, tools and templates
• Develop, track and maintain trials logistical information, systems and tools
• Assist in monitoring of timelines, targets and trial milestones
• Assist is facilitating contracts with sites and vendors ensuring tracking and filing/storage
• Support the tracking and processing of invoices accurately and in a timely manner, escalating any out of scope budget variants
• Organize and schedule appointments/meetings, internally and externally, as necessary and prepare minutes of these meetings
• Coordinating of administrative tasks with trial CROs and sites
• Tracking the quality of vendor deliverables and escalate findings as necessary
• Assist with Vendor and site selection
• Facilitate the corporation between relevant internal and external stakeholders

• Provide global administrative support to Project Teams.
• Being responsible for coordination, oversight and completion of administrative functions on assigned trials.
• Maintaining assigned data points within Clinical Trials Management System as well as coordinating the team conference calls, documents, complete and distribute meeting minutes for various team meetings.
• Updating project team training trackers, maintain vendor tracking and reconciliation, conduct maintenance and regular reviews and support the archiving process of the study files.
• Coordinate project schedules, estimates, cost control, risk management activities. Support audits and inspections.
• Manage performance dashboards, analyze metrics, event triggers, alerts and determine appropriate follow up for Project Leader or others to act upon. Identify changes in scope and manage changes in the control process. Oversight of study files and support/manage study file reviews.
• Develop and maintain relevant sections of Project Execution Plans. Supported multiple studies in their start-up, maintenance and close-out cycles, giving me a great overview of the processes at all stages.
• Managing numerous studies for challenging clients and general CTC-C tasks simultaneously, while maintaining all project deadlines with minimal to no oversight from study management.
• Recognized as an Subject Matter Experct for the file review process of the department.
• Working with mutiple systems like: IWRS, EDC, SharePoint, CTMS, Preclarus Dashboards, ProjectView and numerous eTMFs.
• Experince with trials in multiple therapeutics areas such as: Rare Diseases, Immunology, Respirology, Oncology, Infectious diseases and vaccines Experience with Blinded and Unblinded studies

• Established a high level of customer service within the team Provided constant quality analysis and feedback for agents
• Assisted the department leader in the direct management of the team
• Established procedures and work ethics towards achieving team and company goals Meeting the daily and monthly SLAs
• Processing emails and taking inbound calls
• Created tickets for the issues of the users in the Oracle based system QHorizon Assisted the users with their technical questions about Infosario SiteGateway Assisted the management with creating the schedule for the team
• Placing kits orders Resolving DCQs