Warsaw, Mazowieckie, Poland
Pharmacist with a robust academic foundation and over a decade of experience in clinical trials management, including leadership roles at GSK and AstraZeneca. Ambitious and innovative, with excellent communication and empathy skills building trust and collaboration within teams and stakeholders. Possesses leadership and problem-solving mindset allowing to navigate challenges and inspire success effectively. Process and business change facilitator. Lecturer at MBA course in Healthcare Integrated with Clinical Research and Biobanking with a focus on Risk-Based Quality Management.
Lecturer at MBA course in Healthcare Integrated with Clinical Research and Biobanking. Topics of lectures include quality and statistics in clinical trials with a focus on risk-based quality management, carrier development in clinical trials, clinical trials phases and designs.
Working in close partnership with the Study Delivery Lead (SDL) on end-to-end operational study delivery activities. Working cross-functionally, with internal and external partners, on clinical study management activities. Responsible for: -monitoring study conduct and progress, identifying, resolving and escalating risks/issues -reviewing and authoring key clinical documents, including the Protocol and Informed Consent Forms, and leading development of study plans -vendor management and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties. -country oversight, acting as a primary point of contact, tracking of recruitment progress, data completeness and compliance, overseeing protocol deviations, risks, regulatory approvals and import license status. -overseeing delivery of clinical supplies, investigational products and all study materials provided by GSK or external service providers and communicating issues/risks to continuity of supplies and proposing solutions as appropriate. -data oversight to ensure the study is inspection ready at all times, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination), and assure that all eTMF documents are complete and verified for quality. -budget oversight – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the SDL. Contributing to the squads (potential Scrum Master role in the Global Study Team) and acts as a mediator by breaking down barriers, strengthening team dynamics, building business agility and embracing change. Working with various systems for clinical trials management such as Veeva Clinical Vault, CDMS, JIRA, Planisware, Study Maestro, Clinical Cockpit, CluePoints, SAP and others.
• Providing oversight to ensure study delivery • Leading/contributing to the preparation of study documents and external service provider related documents • Maintaining interactions with internal functions including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers • Contributing to the planning and conducting of internal and external meetings • Contributing to risk and issue identification, development of mitigation and/or action plans for identified risks and issues • Ensuring that all study documents in the scope responsibilities are complete and verified for quality in Trial Master File • Supporting Global Study Leader (GSL) with project management • Adhering to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times • Handling ePRO related activities and Protocol Deviations Experience with various systems and platforms: Veeva Clinical Vault and Veeva Quality Vault, Angel-CARA, Coupa, IxRS, ePRO, RAVE and other; Local Study Teams support, management and training; Issue identification and management; Taking on assignments on non-drug project work in process improvements and leading improvement projects as discussed, and agreed upon with their manager such as being a mentor or subject matter expert.
-Samodzielne prowadzenie prac badawczych w dziedzinie Farmakognozji i Fitoterapii we współpracy z laboratorium Kosmetologii. -Wykonywanie eksperymentów in vitro i in vivo włącznie z przygotowaniem materiału biologicznego, jego analizą jakościową i ilościową, statystyczną obróbką danych. -Praca z technikami chromatograficznymi, spektrofotometrycznymi i kolometrycznymi. -Przygotowywanie kremów zawierających różne stężenia badanych ekstraktów i frakcji w mieszaninie z filtrami syntetycznymi oraz mierzenie ich faktoru przecisłonecznego. -Sporządzanie raportów, publikacja wyników na sympozjach i konferencjach międzynarodowych. -Uczestnictwo w treningach, wykładach i kursach. -Praca ze studentami: prowadzenie zajęć praktycznych, seminariów i wykładów, pomoc w organizaji pracy, orientowanie podczas pisania projektów naukowych i przygotowanie do prezentacji wyników. -Organizacja wydarzenia uczelnianego pod nazwą EPIFAR—Escola de inverno/Pesquisa e inovação em fármaco e medicamentos (Szkoła, Badania Farmaceutyczne i innowacje leków). -Przedstawiciel studentów w uniwersyteckiej Komisji Etycznej do spraw Doświadczeń na Zwierzętach (Comissão de Ética no Uso de Animais, CEUA).
• Zarządzanie projektami, koordynacja wizytami domowymi i monitorowanie lekarzy i pielęgniarek uczestniczących w badaniach klinicznych faz I-III. • Prowadzenie szkoleń dla personelu i spotkań z kontrahentami. • Raportowanie do Sponsorów i CRO (ang. Clinical Research Organisations). • Kontakt z ośrodkami badawczymi. • Praca zgodnie z ICH-GCP (ang. International Conference on Harmonisation-Good Clinical Practices) i wewnętrznymi SOP (ang. Standard Operating Procedures).