Специалист по клиническим исследованиям/ менеджер

Описание

-------------------------------------------------------------------------------- ▼ Objective Global Start Up Specialist with 16 years of experience within the industry. Successful at consistently delivering the highest quality service. Experienced in multinational clinical trials phase I-IV from site start-up till site closure. I desire an opportunity to integrate the company's staff, given that the organization will provide me a tremendous professional growth and a possible place to apply my skills and experience, contributing to the progress of the organization. -------------------------------------------------------------------------------- ▼ Experience ICON PLC. (Pharmaceutical Research Associates, Inc.) Sr. Global Study Start Up Associate April 2021 - April 2023 / St. Petersburg, Russia Managed and executed the start-up activities related to feasibility of sites and investigators in the allocated clinical trials in compliance with in compliance with EU CTR, local regulations, ICH-GCP, Company and Sponsor SOPs, procedures and protocol requirements to deliver reliable, high-quality data in the countries. Established and maintained professional relationships with internal and external stakeholders. Was acting as Global Sr. Site Activation Specialist with Lead role for Belgium, France, Italy and the Netherlands. Participated in preparing of the Part II and selected Part I documents for submission (incl. translation and redaction,) and to handover the CTA package to EU Submission Hub within selected timelines - completion of EMA templates. Initiated development and periodic submission of regulatory documents to applicable Institutional Review Board (IRB). Managed submission packages and IRB applications; dispatching IRB dossiers to sites for a final approval in close collaboration with project team. Checked the completeness and correctness of all collected documents/materials for Site Activations (using Clinical Trial Management System (CTMS); eTMFs; etc.). Acted as LIEL (Local Import/Export Lead) for Netherlands. As IEDR (Independent Essential Document Reviewer): reviewed & approved for IP Release: Country & Site level documents & approval for Site Activation (Green Light). Sponsor dedicated and WEU IEDR. Successfully activated more than 20 sites in EMEA. Start-Up activities were completed on time, within budget and according to scope due to forecasting per study/per country/per site and proactively identified any risks in start-up and site activation plans to relevant stakeholders, develops, and implements mitigation strategies as required. Ensured proper IRB/IEC submissions in EMEA region utilizing extensive knowledge of FDA, local Regulatory requirements & ICH GCP guidelines. Fostered positive sponsor-site relationships through clear oral and written communications. Covance Clinical & Periapproval Services Limited (Covance Inc.) Senior Start-up Specialist September 2020 - March 2021 / St. Petersburg, Russia Successfully managed the start-up activities, start post country allocation, and end at completion of site initiation visits for clinical trials conducted in Russia. Negotiated clinical trial agreements with sites, shortening the time frame for contracts to be executed to 1 study. Made revisions and customizations of Country and Site Specific ICFs (liaise with IRB/ICE on issues). Prepared submissions to IRB/IEC. Activated sites as per requirements based on Company & Sponsor requirements in timely manner with no rejections. Syneos Health RUS (InVentiv Health, LLC / Pharmanet, LLC) Site Start-Up and Regulatory Specialist II May 2013 - July 2020 / St. Petersburg, Russia Provided local Site ID and Feasibility Support. Managed multidisciplinary start-up activities more than 20 studies providing oversight of the sites, IRB/IEC submissions (Initial, amended, annual and closure MoH & LEC submissions for Russia), including safety notifications as required by local rules. Was responsible for import/export negotiations and obtaining local insurance. Served as a point of contact for the PM (or designee) during startup on allocated projects. Compiled and/or reviewed essential document packages for site activation and (essential document collection from sites). Carried out activities in European countries as Submission Specialist responsible for preparation & submission (Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required in timely manner). Supported the creation of internal training materials on local legislation requirements, including providing input to the team to assist with EC or CA issue resolution at the country level for Russia. eTMF (Company and/or Sponsor), CTMS maintaining. PPD Development, LLC Senior Clinical Research Associate August 2012 - May 2013 / St. Petersburg, Russia Took the leadership of site management in Oncology, Cardiovascular and Endocrinology for the selection & initiation of sites, site monitoring, and site close-out activities via acting as the primary point of contact between site staff and Sponsor and/or Project Team. Conducted the trials at sites in compliance with the approved protocol/amendment(s), with GCP, and with the applicable regulatory requirements. Successfully complied with reporting requirements, using CTMS and other systems. Provided mentoring, training and support to less experienced peers of the team and identifed and raised with Line Manager training and development needs for assigned CRAs that require additional expertise from other parts of the organization or via the use of external providers. ClinStar Europe (USA), LLC Clinical Research Associate November 2007 - August 2012 / St. Petersburg, Russia Monitored and provided site management oversight for assigned clinical trials (phase I- IV) according to ICH-GCP guidelines, FDA regulations, protocol and sponsor SOPs . Developed and demonstrated an understanding of and apply therapeutic area knowledge to assignments and project-related issues. Developed recruitment strategies and an enrollment plan with the investigator and site staff to meet recruitment goals in coordination with the SOP and GCP guidelines. Performed site visits including site qualification, initiation, monitoring and close-out visits. Reviewed site's drug accountability logs per patients and overall monitored inform consents. Negotiated, finalized and managed site payments. Communicated with clinical team members and ensured to participate in team meetings and updates. Appropriately resolved issues related to trial monitoring and management. Participated in various sponsor/project team communication and training sessions. Prepared for and attended Investigator Meetings. Successfully completed internal and Sponsor' audits resulting in minor findings. ClinStar Europe (USA), LLC Project Administrator November 2006 - November 2007 / St. Petersburg, Russia Assisted the Clinical Research Associates and PM in clinical projects. Assisted with the audit of documentation in investigational site or Trial Master File as required Maintained all clinical trial materials in accordance with SOPs and GCP requirements and performed administrative tasks including travel arrangements. -------------------------------------------------------------------------------- ▼ Education Non-State Educational Institution of Higher Professional Education "Baltic Academy of Tourism and Entrepreneurship" 2001-2005 / St. Petersburg, Russia -------------------------------------------------------------------------------- ▼ Certificates ICH GCP E6 (R2), 100% score, The Global Health Network, 2022 Trial Master File Specialist, VIARES Academy Program, 2023 Jira Project Management, Great Learning Academy, 2024 Introduction to Data Science, Great Learning Academy, 2024 Introduction to Data Management for Clinical Research Studies, 100% score, Global Health Training Center -------------------------------------------------------------------------------- ▼ Languages English- Proficient English User C1 (Advanced English) Italian - А1: Principianti-It1 Russian - Native -------------------------------------------------------------------------------- ▼ Areas of Expertise Ethics in Clinical Research International Conference on Harmonization Good Clinical Practice (GCP) Quality Assurance: Audits and Inspections Regulatory Requirements: Applicable international and national regulations FDA Regulation EudraCT and EU regulations VHP submission process Therapeutic Experience:Hepatic Disease (phase III; phase IV); Rheumatoid Arthritis / Recombinant IgG1 (phase I); COPD (phase IV); Diabetes Mellitus (phase III); Endocrinology: Diabetic Peripheral Neuropathy (phase II); Ischemic Left Ventricular Hypertrophy (phase III); Acute Heart Disease (phase III); Acute Coronary Syndrome (phase III); Deep Vein Thrombosis (phase III); Kidney Disease (phase III); Head and Neck Cancer (phase III); Fallopian Tube Cancer (phase III); Select Advanced Malignancies (phase III); Hepatocellular Carcinoma (phase III); Interpersonal & Communication Skills Team Building & Leadership Problem Solving Microsoft Office Proficiency -------------------------------------------------------------------------------- ▼ References (upon request) Ana Kutchava, Manager, Study Start Up, ICON Plc. Dorota Perzyna, Site Activation Lead, ICON Plc. Daria Fotunyants, Associate Medical Director, Syneos Health