Ведение проектов КИ, включая ИБЭ под ключ от разработки документации и подачи в регуляторные органы до сдачи итогового отчета по КИ спонсору и формирования рег досье. Руководство командой от 20 человек.

Projects: Clinical trail of medical divice ( Knee endoprosthesis ) Clinical trail phase II (COVID 19) Responsibilities: General: General Project Management: ­ Leads the customization of key control documents (e.g., project plans, communication plans, project governance structure, etc.); ­ Controls study running in clinical sites according to approved protocol, ICH GCP Guidelines, applicable local regulatory requirements and respective SOPs; ­ Develops and manages project timelines; ­ Leads internal and external conference calls; ­ Sets clear expectations for the team and establishes roles and responsibilities; ­ Demonstrates an understanding of client needs and manages satisfaction relative to high-quality deliverable; ­ Ensures profitability and utilization targets are met within the scope of work and budget; ­ Communicates milestone billing completion to the Finance Department (Accountant, commercial officials); ­ Coordinates and communicates with clients and all other stakeholders (investigative sites, third party vendors, etc.) to ensure the alignment of planned objectives to activities; ­ Prepares project status documents and reports; ­ Assists in closing down and archiving systems; ­ Performs other daily tasks and special projects that support and contribute to the overall successful execution of the project life cycle; ­ Routinely tracks budget items and facilitates reconciliation for all services against scopes of work; Training: ­ Coordinates, schedules, and maintains a series of global training programs for raters working on clinical research studies; ­ Prepares training documents; ­ Assists in the development of rater training presentations; ­ Facilitates large scale training events (e.g., Investigator’s Meetings, Virtual Rater Training sessions); ­ Works with third party vendors to set up the eLearning workspace for raters according to project specifications; ­ Assists in the development of client training presentations, if applicable; ­ Coordinates and sets up data for system launch as necessary; ­ Coordinates distribution of materials to system end users; ­ Manages escalations of issues as outlined in the Project Plan. Scale Management: ­ Organizes, coordinates, and oversees translation, clinical review, and linguistic validation process; ­ Coordinates activities related to licensing, budgeting, and distribution of scales; ­ Provides oversight for distribution and shipment of scale binders through third party vendors. Clinical Data Sciences: ­ Creates, implements, and maintains the project management and operational support components involved in expert review and consensus rating support for study sites; ­ Communicates with key technology vendors, including vendors of video and audio surveillance equipment and database solutions; ­ Creates, tests, and implements processes and workflows to support seamless management of clinical quality assurance data in study; ­ Leads and coordinates (conducts if appropriate) orientation for study site personnel and remote raters on equipment usage and workflow responsibilities for in-study activities. Media Management: ­ Sets out pre-production, production, and post-production objectives and timelines in accordance to project timeline and key milestones; ­ Manages the timeline and cost of vendors conducting production and translation of all training materials. Duties and Responsibilities: ­ Develops materials including local language Informed Consents and translations; ­ Works in partnership with IRB/IEC and Regulatory Authority on submission and approval-related interactions for assigned protocols; ­ Manages country deliverables, timelines and results for assigned protocols to meet country commitments; ­ Is responsible for quality and compliance in assigned protocols in the country; ­ Contributes to the development of local SOPs, may oversee contract workers (CTCs) and local vendors as applicable; ­ Collaborates internally with Finance, Medical Affairs, Regulatory Affairs, PV, QA, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, and local milestones; ­ Is responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management; Trial Management: ­ Is accountant for coordinators’ work, maintenance of Clinical Trials Master File, etc. ­ Studies all documentation, includes scientific literature on a project; ­ Maintains “Monitor’s File” to use it during visits in clinical sites; ­ Controls visits dates with clinical sites and updates study coordinator with them (upon study coordinator request); ­ Checks reports of a monitor about conducted visits in timely manner; makes corrections in the reports upon monitor’s request ­ Checks data from a monitor regarding study drug and materials accountability on each visit in a clinical site; After sep 2020 continued work as contract position

Responsibilities: General: ­ Professional self-training on the acting regulatory guidelines, international ICH guidelines, appropriate acting provisions of ISO (including ISO 9000, 9001, 9004); ­ Planning and conduct of internal quality control in the clinical sites (conduct of co-monitoring visits) and maintenance of documentation in the company office in order to conduct clinical studies in accordance with acting normative requirements, SOPs, study protocols, GCP guidelines; ­ Submission of the results of internal control to the company management and also submission of recommendations for correcting actions; ­ Preparation of office and clinical sites for contact of independent audits and inspections; ­ Interaction with Quality Assurance Department of sponsor for coordinating of quality control items of clinical studies conduct; ­ Control of collection of documentation and its sending off to sponsor; ­ Development and implementation of internal SOP, working instructions, job descriptions, report documentation forms; ­ Regular revision (once in three years) of internal SOPs and working instructions, their update on the base of results of internal quality control; ­ Distribution of standard operating procedures and working instructions of the company among the company staff, their maintenance, excluding them from usage and archiving; ­ Making out of plan of general trainings for the year and its quarter update; organization of training conduct in accordance with the plan; control of documenting of general trainings; ­ Control of execution of training plans made out by clinical research coordinators for each trials; control of documenting of trainings on projects by clinical research coordinators; ­ Conduct of trainings on SOPs and company working instructions, sponsor’s SOP and also GCP for company staff; ­ Control of sponsor’s SOPs implementation in the work of the company; training of personnel in case of their change; ­ Collection of recommendations from staff for change of the company SOPs and also sponsor’s SOP (if it is required by sponsor); ­ Preparation of individual training plan for the new employee; conduct for the new employee the required training jointly with clinical research coordinators; control of learning of received trainings by the new employee; ­ Maintenance of documentations on the personnel: CV, job description, training records; ­ Periodic (in case of need) submitting offers to the company management referring organization of personnel work; ­ Content of the company library; ­ Maintenance of the file of training materials in general questions (GCP, regulatory requirements, SOP and working instructions); ­ Control of maintenance of training files for medical aspects of the studies by clinical research coordinators; ­ Following rules of business custom; ­ Complying with requirements of company standard operating procedures and working instructions which are appropriate for this position. Before and in time of pre-study visits (PSV): ­ Receipt from clinical research coordinators plans on trainings on projects, their coordination and approval; ­ Approval of communication plans (if applicable) on projects made out by clinical research coordinators; ­ Making out of plans of check of clinical monitors’ reports for each project and control of timeframes of sending of clinical monitors’ reports to sponsor; ­ Making out of plans of check of trial master file maintenance; ­ Control of the maintenance of electronic tracking for the study and maintenance of trail master fail; ­ Control of passing of documents required for submission to manager of Logistics and Regulatory Support Department by clinical research coordinators; Before and in time of study initiation visits (SIV): ­ Receipt of plan of co-monitoring visits for the study from clinical research coordinators; ­ Control of timeframes of sending of clinical monitors’ reports to sponsor; ­ Control of the maintenance of electronic tracking for the study; ­ Check of the maintenance of trial master file; Study running stage (in the course of monitoring visits) ­ Conduct of co-monitoring visits in accordance with plan of co-monitoring visits; ­ Making out reports on co-monitoring visits; ­ Documenting of necessary correcting actions in case of detection of violations in the course of co-monitoring visits, control of execution of recommended correcting actions; ­ Control of timeframes of sending of clinical monitors’ reports to sponsor; ­ Organization of internal audit on maintenance of the trial master file in office for each three cycles of monitoring visits; ­ Control of timetable for sending monitoring reports to sponsor, reporting sponsor about serious adverse events before their total resolving; collections of queries; ­ Control of execution of trainings on study; ­ Control of submission to sponsor in appropriate terms the documents, monitoring reports, resolved quires collected from sites; ­ Control of informing sponsor about AE/SAE which occurred in the course of the study and their outcome by clinical research coordinators; ­ Control of the quality of work of depot once in the course of the trial in order to check storage conditions of the drug there. Before and in time of study close-out visits: ­ Organization of internal audit on maintenance of the trial master file in 2 weeks before conduct of the first close-out visit of the site (if applicable) ­ Control of timeframes of sending of clinical monitors’ reports to sponsor; ­ Conduct of joint close-out visits in accordance with co-monitoring visits plan; ­ Control of sending of collected documents to the sponsor.

• Project work in the framework of organization and conduct of clinical trials in Russia and CIS countries; • Medical writing - correction, creation of the main package of clinical research documents - Protocol, CRF, ICF, IB; • Work with investigational sites (selection of research centers and laboratories, contract work); • Organize the work of CRAs; • Monitoring the operation of the CRO; • Participation in the development of a clinical research strategy.

sResponsibilities: General • Keeps professional self-training on medical aspects and applicable regulatory legislation; • Studies the protocol, its amendments, investigator’s brochure and its updates, CRF structure, monitor’s manual, as well as other study guidelines and follows them during study; • Controls study running in clinical sites according to approved protocol, ICH GCP Guidelines, applicable local regulatory requirements and respective SOPs; • Participates in all study trainings initialized by the sponsor or local study coordinator; • Studies all documentation, includes scientific literature on a project; • Maintains “Monitor’s File” to use it during visits in clinical sites; • Fixes visits dates with clinical sites and updates study coordinator with them (upon study coordinator request); • Prepares for his/her every visits to clinical sites; informs the sites about planned actions beforehand in written; • Conducts pre-study, initiation, monitoring and close-out visits according to visits plan and respective SOPs; • Sums up conducted visit with investigators both directly at the end of his/her visit in written; • Keeps in touch with study investigators 24 hour; reports important phone conversations in written; solves any issues with clinical sites promptly and informs study coordinator of them; • Reports about conducted visits in timely manner; makes corrections in the reports upon study coordinator’s request; provides study coordinator with originally signed visit report after its approval; • Is responsible for investigators’ knowledge of study documentation and their responsibilities; as well as for the study file maintenance in clinical sites; • Performs study drug and materials accountability on each visit in a clinical site; • Is responsible for collecting adverse reactions data from clinical sites; • Controls investigators’ answers for queries during monitoring visits; • Collects all necessary study documentation according to ICH GCP guidelines and respective SOPs; • Participates in co-monitoring visits, audits and/or inspections at the office or clinical sites; • Assists to study coordinator in unforeseen issues; Pre-Study Visits Stage: ­ To assist to study coordinator in conducting feasibility and selecting clinical sites for a study; ­ Self-training on the file of scientific documentation of the project, study protocol, investigator's brochure, structure of CRF, monitor manual, SOPs for conduct of PSV, and also participation in trainings on the study, conducted by Clinical Research Coordinator; ­ To submit to study coordinator of questions for conclusion with Sponsor before study beginning; ­ To discuss with study coordinator of the documents collected on PSV; ­ To confirm visit dates with Investigator on request of the study coordinator and informing study coordinator about agreed dates; ­ To prepare of monitor's folder for conduct of PSV and also of letters before and after conduct of PSV and sending them to centers; ­ To conduct pre-study visit according to respective SOPs; ­ To check of sites possibility to involve the necessary number of patients and other abilities for study conduct (including laboratory, premises for storing of documents and drug, equipment etc.); ­ To submit to study coordinator after conduct of visit of objective characteristics of clinical site in involvement of necessary number of patients and possible quality of Investigators' work in centers; ­ To collect documents in clinical site on the visit in accordance with SOP; ­ To pass to study coordinator of the documents collected in clinical site and visit report in terms stipulated in SOP and in Section “General”; ­ To make reports on phone talks with clinical sites; Before and in time of study initiation visits (SIV): ­ To review all study documents to collect at SIV; ­ Participation in project trainings; ­ To confirm the dates for initiation visits with Investigators and inform study coordinator about agreed dates; ­ To prepare of monitor’s folder to SIV conduct and also of letters before and after SIV conduct; ­ To send to clinical site letters referring the future visits; ­ To conduct initiation visit according to respective SOPs; ­ To check drug availability in clinical site in accordance with supplied quantity, storage conditions of drug in the site and also check of availability in the site of necessary study materials in sufficient quantity; ­ To collect documents in clinical site on a visit in accordance with SOP; ­ To send letters after conducted visits to clinical sites; ­ To make reports on phone talks; ­ To pass to study coordinator the documents collected in clinical sites and also of visit report in terms stipulated in SOP and in section “General”; ­ Is Responsible for completion of investigator’s site file in clinical site in accordance with SOP and Sponsor's requirements; Before and in time of monitoring visits; ­ To agree dates of monitoring visits with Investigators upon request of study coordinator and informing about agreed dates; ­ To participate in all study meetings or discussions initialized by study coordinator or Sponsor; ­ To update monitor’s folder before each monitoring visit; ­ To send to clinical sites letters about future visit; ­ To prepare the list of CRFs to check and collect (if applicable) during visit in clinical site; ­ To conduct monitoring visits according to respective SOPs; ­ To discuss updated study documents with Investigators; to explain them important details with documenting these discussions in monitoring report; ­ To account study drug and check of storage conditions of the drug in clinical site; ­ To check Investigators to keep study running according to study protocol; ­ To verify CRF with patients' source documents, to collect CRF in timely manner; ­ To control work of Investigators; to detect mistakes made by them or protocol deviations; ­ To control adverse events occurring in the course of the study and timely submission of all information about them with documenting them in monitoring reports; ­ To verify solved queries in clinical sites during monitoring visits, to collect and pass of originals them to study coordinator, if applicable; ­ To send to clinical sites letters after conducted visits summarizing work of Investigators and unresolved issues; ­ To pass to study coordinator of the documents collected in clinical site and also of visit report in terms stipulated in SOP and section “General”; ­ Is responsible for completion of file of clinical sites in hospitals in accordance with SOP and Sponsor's requirements; ­ In case of need assistance to study coordinator in solving of problems connected with improvement of patients involvement (search of additional sites, other conclusions); Study Close-Out Stage: ­ To confirm documents to collect during close-out visit; ­ To participate in all study meetings or discussions initialized by study coordinator or Sponsor; ­ To confirm close-out visit dates with Investigators and inform study coordinator about agreed dates; ­ To prepare monitor's folder for conduct of COV, and also of letters before and after conduct of COV; ­ To prepare and send to clinical sites letters about future close-out visits; ­ To conduct close-out visits according to respective SOPs; ­ To perform final study drug accountability at clinical sites before shipping it for destruction; ­ To collect documents in clinical sites on visit in accordance with SOP; ­ In case of need, to collect delivery and acceptance certificates and other internal documents; ­ To send to clinical sites letters after conducted visits with results of work of Investigators and expressing thanks for cooperation in the project; ­ To prepare of the investigator’s site file, CRF and out-patient medical records for archiving in clinical site; ­ To pass to study coordinator the documents collected in clinical site; ­ To pass study coordinator the visit report in terms stipulated in SOP and in section “General”; ­ To complete study after its close-out (interact with clinical sites in receiving of additional and missing documents requested by Sponsor after closing of site).

• Maintain Site Master Files • Submission to the LEC new safety information • Provide with the data into the electronic CRF's visits conducted according to the source documentation • Send to the Central laboratory of bio samples • Receipt, storage and distribution of investigational product. Projects: diabetes mellitus type 2 , phase III, Urology, phase III , IBD, phase III

Responsibilities: • To prepare and conduct all site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and close-out visits according to relevant SOPs. • To identify potential sites for a proposed study in conjunction with the Project Team, and conduct feasibility assessment of sites as required. • To ensure that investigator site files are assembled appropriately and that all required documentation is in place prior to release of clinical supplies • To be proactive in all dealings with study sites. To ensure that all study related communication including e-mail is tracked, printed and filed as required. • To track patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and LCRA. • To deal with local or central laboratories in order to ensure adherence to the protocol. To ensure that all relevant documentation is current e.g., accreditation certificates, normal ranges, etc. • To prepare, or facilitate the preparation of Multicentre and/or Local Ethics Committee / IRB submission documentation as defined by local requirements. To ensure that EC/IRBs are updated regarding protocol amendments, SAEs etc. • To distribute and track clinical trial supplies, e.g. CRFs, study medication, lab kits. To ensure that sites have sufficient supplies to continue recruitment. • To assist in the CRF writing and review process. This also includes production of Diary Cards, eCRF page formats, and other patient related data capture tools. • To track CRFs collected during monitoring visits to data management. • To liaise with data management regarding data flow and data query processing. • To ensure that the interim safety reports are provided to EC/IRBs as per country requirements. • An understanding of the purpose of Chiltern's Clinical Project Management System (CPMS), how to use it, and how to navigate within the different sections. The ability to enter weekly details on Chiltern’s Project Management System. • To raise invoice requests for investigator payments in accordance with Investigator/Hospital/Pharmacy agreement terms, to maintain the site financial tracking, producing a list for pending investigator payments and producing payment requests for Chiltern International as appropriate for local country requirements. • To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements. • To be accountable for ensuring that all relevant study documentation is present for study sites. • To undertake other project related tasks, as assigned by the Project Manager and LCRA. • To document all study activities including investigator contacts using relevant forms. • To liaise with all other appropriate departments within Chiltern International to ensure the smooth running of the study. • To assemble files and ensure documents for the Sponsor File accurately reflect the progress of the study. • Developing relationships with 3rd parties and reviewing quality of services • Conduct all activities according to the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements • Contribute to the departmental on-site Quality Control programm by setting a schedule of site assessment visits for the project for agreement with the Clinical Monitoring Management Team, and conducting agreed co-monitoring visits with members of the Clinical Monitoring project team. • Ensure awareness of project-specific quality and performance standards (within Clinical Monitoring Standards) and ensure that these are adequately documented, communicated and understood. • To support the development and delivery of department training days. To attend all relevant training and SOP training sessions. • Actively participate in training sessions and workshops, including presenting reports from any conferences attended • Ensure timely completion and documentation of all training requirements. • To liaise with other members of the Chiltern International Project Team and clients effectively. • To maintain awareness of current development in the therapeutic areas relevant to his/her project(s), by reading scientific and medical literature. • To undertake non-project related tasks as appropriate as assigned by the Manager • Ensure timely and accurate completion of expense reports in strict adherence to the Chiltern and/or sponsor travel policy(ies) • Provide supportive information for and participating in sales presentations and bid defense meetings Projects: COPD, 2 projects, phase III, sites 10, the same, 142 pts, 100% SDV

Responsibilities: • Medical writing, preparation of clinical part of registration dossier (Protocol, IB, ICF, PSURs…) • Budged preparation • Quality assurance (SOPs, SFs, WIs preparation) • Quality control (trainings, co-monitorings) • Perform of system audits of new CROs. • Management CROs and laboratories of conducting pre-clinical trials and BE trials. Projects: Erectile dysfunction, BE, Arterial hypertension ( 3 projects), BE

Responsibilities: • site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with GCP and applicable local and international regulations and SOPs • ensure quality of data submitted from study sites and assure timely submission of data including appropriate reporting and follow up for all safety events by site personnel • perform feasibility studies (pre-study site selection) • function as Lead CRA for global studies, coordinating CRAs, reviewing monitoring reports • provide mentoring and coaching colleagues and site stuff when needed • design monitoring tools as requested • provide support of the design of CRFs and protocols as requested • develop monitoring plans when required • actively participate in study team or investigator meetings • conduct training for colleagues or study team as requested • manage a cost center and implement appropriate actions to keep within budget • Collect Site Regulatory Documents and perform primary Quality Control of SRD • Perform all kinds of investigator site visits, manage investigator sites between visits • Assure adherence to the protocol, GCPs, SOPs and take necessary action to bring about compliance • Handle CRFs and DCFs and perform in-house CRF review • Facilitate adverse event reporting • Participate in preparation for and to assist during audit/inspection at investigator sites • Assist in preparation for and to participate in Investigator meetings and participate in study team meetings • Maintain a site specific part of the Trial Master File • Fulfill administrative tasks • Perform co-monitoring visit to investigator sites • Supervise and train CRAs Entry Level • Conduct trainings for study team as requested by Project Manager Projects: Rheumatology, phase II ( SLE, lupus nephritis ) Psychiatry, phase II Alzheimer Disease Anti-Nicotine Vaccine

Responsibilities: • Site selection, regulatory submission, site initiation, clinical study monitoring, • Data collection and clarification, quality control, review of data collected at trial sites to ensure compliance with Protocol and ICH GCP guidelines, safety control, negotiate study budgets, obtain, and review for appropriateness, process regulatory and administrative documents from the investigator sites, close-out activities. • Participate in Sponsor’s phone conference and life meetings • Communication with Sponsors, site staff and vendors Team Leader’s responsibilities: Team Leader was since 2008 year. Was involved in 3 projects. 2008-2010 adolescent schizophrenia, 4 CRAs and Project coordinator in subordination to Team Leader 2010-2011 mCRPC, 3 CRAs and Project coordinator in subordination to Team Leader • Coordinated feasibility process, assist to CRAs for site selection • Adapt ICF to Local requirements • Approves Protocols and IBs after translation on Local language. . • Reviews and approves the initial regulatory submission • Reviews and approves the Green-light package for start sites initiation process Organization team work, train CRAs at sites and in-house ( study –related trainings ) • Perform co-monitoring visits • Support CRAs in all study activities • Preparation sites with CRAs for audits. Projects: Oncology ( phase II ) – 2 projects ( mCRPC ), Psychiatry (phase III)-2 projects (adolescent schizophrenia), Gastroenterology ( Phase III )- 2 projects ( IBD ), Nephrology ( phase III ) - 1 project ( CRL ) Pass four audits successfully.

Full CRA responsibilities • feasibility process and site selection • Regulatory documentation collection, submission process • import/export license preparation and submission • monitoring visits, data review, planning and reporting, site management, trip preparation/follow up • collecting site documentation • payments • close-out visits Projects: Oncology (phase II-III)- 3 projects ( small cell lung cancer, colon cancer), Psychiatry (phase III)-5 projects ( schizophrenia, bipolar disorder, depression), Pass two audits successfully.