Katarina Valova

Katarína Valová Košice, Slovakia -- linkedin.com/in/katarina- valova-b8b7a1168 EXPERIENCE Freelance Medical Translator Mar 2025-present Languages : CZ-SK-ENG Scope: Cover letters, ICFs, Protocol Synopses, IFUs Medical translations between above mentioned languages while maintaining high standards of accuracy in translation to avoid miscommunication and potential harm to patients. Previous job experience and education equipped me to achieve clear, concise, and accurate writing in both the source and target languages. In depth knowledge of medical concepts, procedures, and terminology, especially in clinical trials and towards patients. Site Contract Leader, Freelancer Consultant | Parexel, Prague (Decentralized)Feb 2022-Mar 2025 Act as functional Leader on projects and develop study specific CSA strategy • Drafting legal language and creating budgets for CSA negotiations based on protocol and SoAs • Customizing site specific documents and questionnaires based on protocol • Agree and negotiate study specific CSA templates with the Sponsor and Site as applicable • Communicate CSA strategy, CSA turnaround timelines, tracking requirements and budget information/updates with key stakeholders. Coordinate interaction between Parexel study team and Sponsor as applicable to include but not limited to overall timeline management for CSA delivery. • Provide updates about template amendments, process changes, investigator fees, local requirements etc. to ensure that relevant CSA database is maintained in real time • Early recognition of areas of potential problems and formulate contingency plans • Define solutions strategy of significant CSA changes requested by the site • Participate in client and team meetings • Identify and facilitate CSA training needs as applicable • Prioritize effectively and respond to urgent requests within team or sponsor lead • Maintain a working knowledge of and ensure compliance with applicable ICH-GCP • Guidelines, local regulatory requirements, and PAREXEL SOPs and study specific procedures • Complete routine administrative tasks in a timely manner (e.g. Timesheets, metrics, travel expense claims) Trial Capabilities Associate|Eli Lilly and Company (Cork Ireland) Oct 2019- November 2021 Study Startup Lead- Account centralization process SME • Member of the newly created Account centralisation team within the Trial Capabilities department- specialised for startup and site activation, on global level for EMEA • Responsible for Account centralisation process set-up • Coordinating roll out of the process outside EMEA region • Serve as Training Lead and SME for the process , owner of the training materials, acting as the primary point of contact for Q/A • Close follow-up and review of the issues of the process roll-out Study Startup Lead- Site activation Lead • Serve as study start up lead for a diabetes study for EMEA region; acting as the primary point of contact between the study team and the associates of each country involved in the trial of EMEA region. • Coordinating all the start-up activities from the site feasibility to the activation of the last site in the region. • Attending weekly meetings with the study team, updating the activation status of the region. • Updating trackers of Enrollment Ready Status of the EMEA region and providing information to the Project Management Team. • Close follow-up and review of the different activation processes with Clinical Project Manager (resolving issues, creating presentations, suggestion of new processes). Regulatory Manager • Compilation and submission of Clinical Trial Applications to Regulatory Authorities and Ethics Committees within Slovakia and Czech Republic. • EU-CTR transition country specialist • Responsible for Study Start-Up and site set-up, study maintenance and close out. Focused on initiation of phase II/III clinical trials in therapeutic areas of Oncology, Diabetes and Biomedicine within the company’s EMEA Trial Capabilities department. • Acting as Informed Consent Forms Subject Matter Expert and conducting regular reviews of related SOPs. • Create/customize of study specific clinical trial documents including informed consent forms, synopsis, annual progress reports, end of study reports based on protocol and study data. • Review of study documents including review of translated submission documents. • Translation of selected documents such as ICFs, patient facing materials, synopses, parts of protocols if needed, site facing materials. • Serve as local expert in project startup activities for a particular county or region. • Develop and produce metrics and status reports to support the needs of Project Managers. • Responsible for maintaining the eTMF compliant at country and site level. • Mentor of new team members and reviewing their submission packages. • Communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully executed contract. Active communication with sites regarding invoice and payment related issues. • Overall, responsible for keeping good relations between sites, especially principal investigators, and the company. Pharmacology department Intern | University of Porto (Porto, Portugal)Jan 2019– Sep 2019 • Involved in in-vivo and in-vitro cytotoxicity research in the field of oncology • Acquired knowledge and understanding of pharmacological research, developed practical skills in manipulation with human breast cancer cell cultures (sterile media preparation, mycoplasma screening, ..) • Methods and techniques review and set up the project strategy based on available data • At the end was able to analyse and interpret obtained data and present the research outcomes, • Scientific thesis reviews • Practical experience in manipulation with Lionheart FX, automated microscope with data collection and analysis and assisting during the laboratory animal operations Pharmacist | Moran Pharmacy (Prague, Czech republic) Sep 2018 – Jan 2019 • Full time job position in public pharmacy • Providing drug information to patients and communicating medical information to healthcare professionals Pharmacy Intern|Farmacia Alianca (Porto, Portugal) Jun 2018 – Aug 2018 • Internship in public pharmacy focused on alternative medicine such as homeopathy or phytotherapy, Pharmacy Intern|Benu Pharmacy Andel (Prague, Czech republic) Jul 2017 – Feb 2018 • Internship in public pharmacy Hospital Pharmacy Intern|General University Hospital (Prague, Czech republic) • Internship in hospital pharmacy at different departments- gained practical experience in sterile and non-sterile compound preparation Laboratory Intern|Medirex (Kosice, Slovakia) • Internship in toxicology and biochemistry laboratories of Medirex group EDUCATION PharmD-Faculty of Pharmacy Hradec Kralove, Charles University in Prague, Czech republic, Jul 2023-present MSc-Faculty of Pharmacy Hradec Kralove, Charles University in Prague, Czech republicSep 2012 – Sep 2018 LANGUAGE SKILLS • Slovak – Native • English, Czech – Fluent • Portuguese - Beginner OTHER SKILLS • Microsoft Office - Word, Excel, PowerPoint, Outlook • electronic Trial Master File - VeevaVault • Clinical Trial Management System • Interactive Web Response System • Medical and scientific writing