Maryna

Marina Tkacheva

Tel: [відкрити контакти](див. вище в блоці «контактна інформація»)
Email: [відкрити контакти](див. вище в блоці «контактна інформація»)
Employment History
Eli Lilly Ltd., Cork, Ireland July 2022-Present
Senior Manager for North America Maintenance; People Management, Line Manager. July 2022-Present
• The Senior Manager Clinical Trial North America Maintenance Team leads the North America Maintenance Team in support of clinical development. This includes leading the countries (US, Puerto Rico, Canada) in the region that support global clinical development. In this role the Senior Manager is accountable for site maintenance/close-out, site contracts amendments, records management, training, and trial metrics across all therapeutic areas. The Senior Manager will serve as the point of contact for Competent Authority (CA)(where applicable), assist in budget and contract negotiation if needed. Additional local responsibilities may be required as needed/appropriate for the local geography, and/or to cover regional differences.

• The Senior manager is accountable for the prioritization, planning and implementation of site maintenance activities working closely with the North America Maintenance team, site engagement, global study teams and the design hub ensuring accurate planning, prioritization and timely execution to meet portfolio needs.

• The Senior manager provides leadership, direction and technical support to the North America Maintenance Team, focusing on results and driving efficiency to achieve goals and objectives. The Senior manager will ensure inspection readiness at all times by following GCP requirements and through a complete, accurate and readily available Trial Master File .
IQVIA, Kiev, Ukraine – June 2021-July2022
Study Start Up Manager June 2021-July 2022
• The SSU Manager is responsible for providing customer-focused leadership in the execution of operational strategy and management of start-up activities for projects or programs. This includes the overall management and oversight of the following processes: site feasibility, regulatory approval, and site contracts. They may be assigned to manage the site start-up activities for a country, region, or entire global trial.
• The SSU Manager also has responsibility for maintaining internal tracking for study site status from initial site contact through site initiation. This position works directly with Director of Clinical Monitoring, VP Operations, Project Managers and Clinical Trial Managers in setting priorities for study start up. This individual works with the VP of Operations to set forward looking strategy for the Department as it strives to meet its internal objectives to support overall IQVIA Biotech top and bottom line performance
• The SSU Manager is responsible for developing the site activation delivery strategy according to project scope and specifics, indicating the activation projection for sites in diverse countries, site identification, regulatory, contract and start up elements’ timelines.
• Oversee the execution of site activation strategy, focusing in delivering sites in the agreed timeline, budget and within scope, pro-actively identifying and addressing risks.
• Communication with client, project team members and local regulatory specialists on study sites status, activation projections, risks, and opportunities to secure the activation strategy.
• Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines, and project plans with project specific information.

Covance Clinical Development Services, Kiev, Ukraine – March 2020 – June 2021
Site Selection Lead II March 2020 – June 2021
• Develop, in conjunction with the Global Feasibility Lead, the initial site list for feasibility and site identification.
• Full oversight of the Feasibility/Site identification process: survey development and programming, local resource training and oversight, oversight of site outreach process, creation of progress reports, site selection tool and decision making, customer interaction.
• Collaborate with Global Feasibility Leads to support collection of country and investigator feedback in the pre-award space; provide summary and analysis of results.
• Responsible for setup and conduct for feasibility/site identification studies according to timeline and quality standards and client expectations - learning to negotiate timelines or KPIs directly with customers.
• Develop site lists according to the program or protocol:
◦ Work closely with Global Feasibility Lead, strategy, and start up teams to understand optimal site profile
◦ Evaluate the available sources of potential site information, and the pros and cons of each.
◦ Manage timelines and any changes to the target site list requirements up until the site is fully identified and the target number of potential sites in each defined region and country is achieved.
◦ Helping to facilitate identity matching by coordinating the triggers for master data management
• Independently performs literature and internet searches as required.
• Masters and fully exploits all available data sources for site performance.
• Create electronic surveys using company software and produce any required standalone or topline surveys.
• Train and mentor SSL1, and newer SSL2s as needed, on core feasibility processes for all core feasibility tasks required of that role.
• Participate in, contribute and potentially leads process improvement or special projects
• Contribute to (and learn to potentially lead) internal planning meetings, client interactions, and interim teleconferences.
• Ensure accuracy and quality of survey driven data.
• Work with team to identify potential risks and out of scope activity; discusses contingency plans with project management. stakeholders as appropriate.
• Ensure site identification team in each country is entering and updating internal tracking tools.
• Contribute to best practice for feasibility/site identification conduct.
• Contribute and deliver training of feasibility and site identification requirements/processes.
• Liaise with the global, cross-functional teams, inclusive of legal, start-up, clinical, country teams, and contribute to audit presentations/documentation based on site ID oversight.
• Performs any other duties as assigned.

Syneos Health (previously INC), Kiev, Ukraine – Nov 2012-Feb 2020
Senior SSU and Regulatory Affairs Specialist-October 2019-February 2020
• Perform assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials.
• Perform submissions to ethics committees at health care setting and regulatory authorities.
• Review and finalize the essential documents that is required for site initiation.
• Act as main contact with Regulatory Authorities (RA) and ethics committees at health care setting.
• Forecast submission/approval timelines and ensure they are in compliance; if forecasted timelines are not reached to provide clear rationale for delays, to provide contingency plan to mitigate impact, and to escalate the issue as soon as identified.
• Review Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner and to keep training records updated accordingly.
• Make continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities).
• Act as a back-up of SSU colleagues for assigned to them activities during their absence.

Site Access Lead, Feasibility - Jul 2015 – October 2019
• Acts as primary contact and team leader for the site identification and the site selection process forwarded or ongoing trials and/or standalone feasibility projects. Manages all Site Identification activities to ensure quality, on time deliverable that are within budget.
• Complete or obtain the appropriate project forms/documents according to Syneos ( INC )Site Identification Work Instruction, including but not limited to: Starting Checklist, Site Identification Plan (documenting split of roles and responsibilities), Site Identification Checklist, Confidentiality Disclosure Agreement template, Potential Investigator Questionnaire template, Obtain site lists from Operations/sponsor if appropriate.
Site Start Up and Regulatory Specialist II – Nov 2012 – Jul 2015
• Perform assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials.
• Perform submissions to ethics committees at health care setting and regulatory authorities.
• Review and finalize the essential documents that is required for site initiation.
• Act as main contact with Regulatory Authorities (RA) and ethics committees at health care setting.
• Forecast submission/approval timelines and ensure they are in compliance; if forecasted timelines are not reached to provide clear rationale for delays, to provide contingency plan to mitigate impact, and to escalate the issue as soon as identified.
• Review Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner and to keep training records updated accordingly.
• Make continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities).
• Act as a back-up of SSU colleagues for assigned to them activities during their absence.

PRA International Kiev, Ukraine – Oct 2011 – Oct 2012
Regulatory Affairs Specialist, Oct 2011 – Oct 2012
• Perform submissions to ethics committees at health care setting and regulatory authorities.
• Liaise with project team members regarding study regulatory issues.
• Perform regulatory documents collection, review, maintenance and close-out activities, to ensure that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
• Support investigators and investigative staff in fulfilling obligations with regard to submission according to local regulatory and IRB/EC requirements.
• Perform study tracking via CTMS or sponsor designated system to ensure that the regulatory files are current, accurate and complete.
• Document regulatory interactions in a timely and professional manner.
Quintiles Kiev, Ukraine – Sep 2010 – Oct 2011
Clinical Trial Assistant – Sep 2010 – Oct 2011
• Preparation of the Performance Fees and Acts on work completion, communication with Investigators, close communication with clinical researchers and Investigators, up-dating information in all relevant systems InnTrax.
• Document Tracking Spreadsheet; supporting investigators and monitors on all stages of project. Communication with vendors and projects teams regarding payment process, confrontation international laws with locals, time-to time supporting CRAs in preparation for visits, preparing documents for investigators; participated in co-monitoring visits with CRAs, usually involved in audit preparation process and filing.

Therapeutic Experience
• Cardiovascular Disease: Cardiovascular risk, (Phase III)
• Gastroenterology: Colon Cleansing, (Phase IIIb)
• Infectious Disease: Respiratory Syncytial Virus (RSV), (Phase III)
• Infectious Disease: Moderate to Very Severe COPD, (Phase III)
• Infectious Disease: Moderate to Severe Asthma, (Phase I, II, III)
• Neuroscience: Alzheimer’s Disease, (Phase III)
• Oncology: Breast cancer, (Phase I, II, II)
• Oncology: Solid tumor, (Phase I, II, III)
• Oncology: Ovarian cancer, (Phase III)
• Oncology: Lung cancer, (Phase I,II, III)
• Neurology: Duchenne Muscular Dystrophy (DMD) (Phase III)
• Pain: Cancer pain, (Phase III)
• Psychiatry: Bi-Polar disorder, (Phase III)
• Psychiatry: Schizophrenia, (Phase III)
• Systemic IMID: Rheumatoid Arthritis, (Phase II, III)
• Systemic IMID: Musculoskeletal, (Phase II, III)
Language Capabilities
• Ukrainian (mother tongue)
• Russian- (mother tongue)
• English (fluent)
Education
• Master’s Degree in Law and Business, National university of Ministry of Internal Affairs, Kiev, Ukraine, September 2005 – June 2009
• SSU Academy at Syneos Health: Mentee for Site Activation Lead, July 2016- January 2017