Savina Elitova

• Serve as an expert on centralized monitoring studies to support from Applications, Analytics, Therapeutics, Quality perspective.
• Provide centralized monitoring support to relevant stake holders within project team for assigned deliverables.
• Develop study management plans, tools and templates and maintain team accountabilities as applicable.
• Provide technical inputs in developing study specific documents, plans, applications.
• Provide resolution to internal study team on study specific issues highlighted in study.
• Provide inputs to cross functional team in managing project deliverables.
• Provide technical support in setting up Data analytics in study.
• Support Centralized Monitoring Services manager in periodic review of Centralized monitoring trainings and/or identify training needs of team and provide inputs whenever required.
• Support Subject Level Data reviewer (SLDR) and identify any anomalies in patient reported data that require further investigation with clinical site to determine overall accuracy.
• Oversee & perform trigger management compliance and i-site pack delivery. Provide technical support in conducting in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data).
• Conduct periodic review of site level key risk indicators and historic site performance according to Clinical Operations Plan.
• Early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk.
• Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit).
• Review effectiveness of recommended actions and take appropriate additional actions if no effect is observed.
• Act as point of contact for assigned deliverables for customer or projects/specified.
• Monitor operational triggers/Key Data Points/data trends and monitor their compliance check by performing regular Quality Check.
• Mentor projects/ initiatives on industry best practices
• Evaluate quality and integrity of study site practices related to th
  proper conduct of protocol and adherence to applicable regulations. Establish and maintain effective project/ site level communications with relevant stakeholders. Maintain relevant project documents.
• Act as Project Oversight to site management activities on assigned projects and evaluate quality and integrity of study as per protocol, standard operating procedures, respective regulation and guidelines. Collaborating with peers and promoting cross functional synergies.
• Attend Kick-Off meetings, weekly team meetings, and client meetings, as per project specific needs.
• Coordinate efforts of cross functional project teams to support milestone achievement and to manage study issues and obstacles.
• Review reports per annotations, SOPs, guidelines,
• Identify issues and escalates same as appropriate, prepares annotations and conducts CRA trainings, conducts monthly SRS-CL calls to discuss major issues emerging from trends noted during report review, etc.

• Performed complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines
• Established and maintain effective project/site communications
• Created and maintain relevant project documents/trackers
• Ensured accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
• Reviewed, evaluated and recommended modifications to designated processes
• Oversaw and participate in document management (creation, review, maintenance, storage, as applicable)
• Participated in (study) team meetings and implement action items
• Collaborated with the project lead/team members in creation/review of study documents including quality manuals
• Acted as point of contact for assigned deliverables for specific customers or projects
• Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
• Escalated quality issues to relevant stakeholders and/or line manager
• Coached junior clinical process associate/specialists

• Coordinated and delivered clinical trials pharmacy support to researchers across institutions.
• Strategically planned and deliver workload for Clinical trials pharmacy.
• Ensured that Pharmacy procedures relating to clinical trials involving Investigational Medicinal Products (IMP’s) are in accordance with appropriate regulations (ICH/GCP, EU Directive 2001/20/EC, FDA, GMP) and with Research Governance Framework.
  • Provided highly specialized professional expertise to Researchers in development of clinical trial protocols involving medication and related substances and to provide advice & information regarding application for Clinical Trial Authorization (CTA) certification from MHRA.
  • Ensured compliance with relevant standards for operation and management of Clinical Trials.
  • Advised and support researchers in complexities and feasibility of trial design and Research Ethics Committee applications, particularly in relation to obtaining a CTA.
  • Liaised with other centres for clinical research to ensure common standards of practice.
  • Acted as a source of Research expertise to advise on complex issues such as trial design, procurement, randomization, blinding, and documentation for in-house clinical trials and to defend/justify opinions or decisions if advice is challenged.
  • Advised research staff and practitioners and Research & Development (R&D) of pharmacy developments regarding clinical trials.
  • Developed Pharmacy policies and procedures to support the delivery of clinical trials involving medication and related substances. Oversee the production, implementation and review of detailed written pharmacy guidance and SOP’s and liaise with pharmacy teams across the Trust to ensure effective implementation of these SOP’s and initiate change if necessary.
  • Ensured R&D approval, ethics approval and the Medicines and Healthcare Products Regulatory Agency (MHRA) approval are all in place before any clinical trial commences and drugs are issued from pharmacy in liaison with investigators and members of the research team.
  • Communicated with investigators, clinicians, research practitioners, colleagues within pharmacy department and the NHS, pharmaceutical company monitors regarding pharmacy aspects of clinical trials for all patients.
  • Liaised with other centres for clinical research to ensure common standards of practice.
  • Advised investigators on pharmacy legal requirements for clinical trials.
  • Developed, validate and implement training documents and procedures such as standard operating procedures (SOPs) in the light of service change
  • Planned and organize relevant research and audit activities across disciplines where appropriate.
  • Assisted in identifying risks from medicine use and handling in the service and support the design, implementation and audit of strategies to minimize them.
  • Line-managed direct reports to include performance management, appraisals, regular one to one’s, objective/target setting, personal development plans and attendance monitoring.
  • Was responsible for training pharmacy staff in ICH-GCP pharmacy accountabilities.
  • Trained medical nursing and pharmacy staff in all aspects of handling drugs in clinical trials

• Delivered clinical pharmacy service to the Oncology Directorate to optimize medication for the individual patient
• Medicine reconciliation at admission and discharge
• Attended at regular consultant ward round/s to advise on optimal prescribing
• Served as a liaison between Pharmacy and Directorate clinical areas to improve medication delivery and turnaround
• Participated in clinical pharmacy meetings and contributed to the clinical/ward pharmacy service as appropriate by liaising with all pharmacists and departmental management
• Provided highly complex medicines information to patients, caregivers, doctors, nurses and other healthcare professionals
• Assisted in identifying risks from medicine use and handling in the service and support the design, implementation and audit of strategies to minimize them.

• Organized appointments and meetings with community- and hospital-based healthcare staff
  • Identified and establishing new business
  • Demonstrated or presented products to healthcare staff including doctors and pharmacists
  • Met both business and scientific needs of healthcare professionals
  • Attended and organize trade exhibitions, conferences and meetings
  • Wrote reports and maintain documentation