Alexandra Sardareva

As part of G.OPS team my responsibilities include the following processes:

• Pre-Site Selection Visit Reconciliation

• Feasibility and Clinical Trial Agreements Filing in Apttus

• In start-up phase, supporting the study lead in creating study specific folders

• Assisting study lead in effective management of eTMF and its Inspection Readiness, performing Functional QC

• Performing Completeness Assessment

• Updating RDMS

• Establishment and maintenance of Study in Gilead's Global Clinical Trials Management System (GILDA)

• Update RDMS

• Assisting the study lead in preparing reports and trackers to track various metrics (electronic data capture report, action items, Protocol deviations

In this role my duties were to assist and support CRAs in their everyday work incl.:

• Tracking the availability and collection of site-specific documents for all relevant site personnel within agreed timelines (ex. FDF, CV, GCP certificates etc.)

• Tracking the subject, site and visit status and milestones in CTMS

• Maintaining ICF Completeness tracker before COV

• Collect, organize and maintain clinical trial documentation incl. filing and reviewing documents for accurate content

• Coordinate on-site MVs, create and update SMVs calendar

• Assist in co-ordination of SMOs, Institutions and Investigators payments, e.g. entering HAs fees in CTMS and collecting invoices

• Maintain study documentation in application systems, e.g. uploading files to eTMF

• Communicate with study sites. Coordinate ordering, shipment and tracking of trial materials to ensure that sites have received study lab supplies, IP, devices, motivational materials and will use them according to study procedures

• Provide general administrative support to the CRAs, e.g. filling trackers, coordinating webinars and trainings for Study teams provided by the Sponsor, tracking study data in EDC systems for accuracy and completeness, tracking the distribution of Confirmation letters and FU letters.

• Work with strict timelines and tight deadlines

In my role as a Corporate Comms Specialist I was responsible for:

• Building and maintaining excellent relationships with Medical Doctors, coordinating partnership with Professional Medical Societies, Patient organizations, NGO’s and government agencies. Assisting in the organization of round tables and conferences.

• Monitoring and organizing Actavis' media presence, building relationships with journalists, preparing monthly media coverage report

• Writing and disseminating communications materials such as press releases and internal announcements

• Managing digital platforms including corporate website, recruitment sites and social media. Responsible for GDPR compliance implementation.

• Collaborating with different internal divisions to execute the overall PR, CSR, and employer branding strategy. Working in close collaboration with CComms team in Switzerland applying the communications strategy locally

• Preparing corporate agendas and itineraries, co-coordinating directors visits, arranging meetings, writing letters, preparing presentations
• Maintaining office premises, followed up contracts for office equipment
• Dealing with hotels and travel agencies, negotiating accommodation rates, planning, and organizing business trips, preparing corporate agendas and itineraries, processing monthly expense reports