Seasoned Medical Doctor with over 7 years experience in clinical trials. Graduated from Medical University of Warsaw in 1996. Specialized in pediatrics. Worked for 13 years in the Clinic of Oncology at Children’s Memorial Health Institute in Warsaw, Poland as pediatrician and co-investigator mainly in Phase II-III trials. Combined his hospital practice with extensive ambulatory services for pediatric patients what he continues until present. Between 2002 and 2009 worked for two CROs as Clinical Research Specialist, Project Manager and the Head of Clinical Operations. Gained significant experience in Phase I studies. Used to manage clinical trials in various therapeutic areas: oncology, hematology, anesthesiology, allergology, endocrinology, gynecology, nephrology, infectious diseases and rheumatology.
Seasoned leader with 13 years industry experience across multiple functional areas – site start-up, site contracting, vendor management, strategic alliances, sponsor contracts, clinical monitoring, data management. Oriented on delivery, growth and development. During last 10 years has been developing, growing, leading and mentoring several medium-to-large teams across the globe. Individually developed or participated in development of departmental processes, policies, cross-functional strategies, budgets, as well as internal regulations. Experience goes across both direct and functional line management, with attention to managing virtual teams located across the world (including management of directors and associate directors). Led multiple contract support teams assisting organizations in contractual matters worldwide. For two years in charge of a pivotal Functional Service Provider team, a group of 60 leads and contract negotiators dedicated to a medium size pharma company. Author of several training programs in contract management area.
Matured professional with over 20 years experience in clinical trials gained in the world’s biggest CRO. Used to manage clinical components of large, global and multi-national studies across different regions. Her responsibilities included management of the clinical study team, project budget, timelines, and quality of deliverables. Supervised all stages of project life cycle from study design, proposal development through start-up and maintenance phase to project closeout and marketing authorization. Relevant experience in EMA inspections and audits. Her professional experience also covers several years of liaison between CRO and large pharma customers in Central & Eastern Europe and optimization of CNS studies delivery from internal and external perspective.
Specialized in processes improvement, innovations implementation in clinical operations and project management environment (e.g. electronic Trial Master File, SOPs management, project management standards, GCP Accreditation, centralized site visit reports review, etc.). Focused on developing tools and trainings to enhance Clinical Team Leads and Clinical Project Managers performance.
Spent 15 years in scientific laboratory research in the fields of immunology, transplantology, experimental surgery, and oncology at the Institute of Oncology and Polish Academy of Sciences (Department of Experimental Medicine).
Graduated from Medical University of Warsaw in 1996. Worked for 10 years as a surgeon in the University Department of General and Digestive tract Surgery and in the Clinic of Digestive Tract Tumors at the Institute of Oncology in Warsaw. In parallel joined pharmaceutical industry in 2000 supporting Clinical and Project Management organizations, filling various positions from CRA and Project Manager through Global Clinical Team Leader, Head of Eastern Europe and Middle East Project Management Group, Program Director to Clinical Project Management Director in Real World & Late Phase Research organization. Later on took over Director responsibilities in Business Organization & Optimization department being responsible for improvement of global RWLPR delivery processes in the world’s biggest CRO.
In 2011 co-founded MDM Medical Health Center in Warsaw where he occupies position of the Member of the Board and Medical Director supervising clinical trials administration, organizes tailored training for surgeons on novel approaches in vein surgery offered in the clinic. Between 2016 and 2017 worked for Med-Net CRO as Medical Advisor.
In 2017 founded ClinPart, Central Services company supporting biopharmaceutical industry in clinical studies management.
Graduated from Warsaw University in Poland with a degree in Physics. Experienced quality professional with a positive “can do” attitude, driven to protect and strengthen an organization by making sure that stakeholders’ needs and expectations are met consistently. Has 19 years of in-depth experience in the Clinical Research industry working for the world class leading CRO. Moved to quality management in 2004 and has served as the regional (EMEA) Quality Management Head being responsible for the operational quality strategy and leading the team of Quality Managers across EMEA region. Specialized in operational quality management, regulatory compliance and inspections, quality risk assessments, root cause analysis, CAPA strategy, continuous improvement, QMS design, and change management.
Graduated from Medical University in Poznan in 1989, where he gained his MD. Used to work as pediatrician and then for 9 years in Medical University in Poznan, Pediatric Hematology and Oncology Clinic. Experienced clinician, university teacher, researcher and Principal Investigator. His PhD dissertation in pediatric hematology received the Award of President of Medical University of Poznan, Poland. In 2004 joined pharmaceutical industry as Medical Advisor, then Medical Director for Eastern Europe and Global Associate Medical Director in several top pharma organizations. Specialized in oncology, hematology and hemophilia areas. His experience includes medical writing, professional translations from and into English, clinical trials phase I-IV advisory, numerous publications and presentations, organization of advisory boards, satellite symposiums, and experts’ panels. He also has been involved in post marketing surveillance, observational studies and Investigator Initiated Studies. Graduated Management and Organization in Healthcare, Project Management and Higher Linguistic School in Warsaw. Laureate of Scholarship of Children’s Medical Care Foundation, Washington, USA and Scholarship of American Center of Polish Culture, Washington, USA.