Karolina Patrycja Kłosińska
Warszawa
Summary
Karolina is a motivated, problem-solving Clinical Team Manager within Project Delivery with 20 years of experience in the clinical research industry, including over 10 years of experience as Project Manager. Her depth of experience managing clinical trials consists of phase II, III, and IV trials including the protocol development, implementation of study protocols, regulatory, feasibility, site selection and activation, patient enrollment, clinical monitoring, data management oversight, close-out activities across EMEA. Karolina holds a master’s degree in Pharmacy from Warszawski Uniwersytet Medyczny (Medical University in Warszawa).
Overview
14
14
years of professional experience
Work History
Clinical Team Manager
PPD, part of ThermoFisher Scientific
10.2021 - Current
- I drive and own the clinical deliverables at a regional level ensuring that quality, timelines and resources are maintained and adequate.
- I lead the development of the monitoring strategy at a regional level identifying emerging risks and bringing solutions when issues arise.
- I utilize data sources available to proactively identify emerging risks.
- I provide project-specific training, leadership and therapeutic knowledge to the team (CRAs, CTAs, SSU team, Contracts team) to achieve project goals and maintain motivation.
- I ensure that the assigned team executes their responsibilities in accordance with ICH GCP, protocol and applicable SOPs.
- I partner with Project Lead and sponsor to address any out of scope tasks.
- I collaborate with the Project Lead, Project Functional leads and other stakeholders to prepare, organize and present during internal or external meetings.
Regional Clinical Trial Manager
DOCS (FSP for Amgen)
07.2020 - 09.2021
- I led priority NSCLC studies in top-recruiting country.
- I oversaw preparation to interim analysis, achieving significant improvement in data flow and data quality.
- I collaborated with client’s Global CTM and with country teams to ensure timely and in scope clinical delivery of the studies in assigned countries.
- I identified risks, implemented risk mitigation strategies and resolved issues at a regional level.
Country Manager and Project Manager
Navitas Life Sciences (previously EcronAcuNova)
04.2018 - 07.2020
- I executed and managed assigned clinical studies, acting as the main point of contact for sponsor and for project team members.
- I supervised project team members, recruited new employees, participated in bid defense meetings.
Country Manager and Senior CRA
Navitas Life Sciences (previously EcronAcuNova)
04.2012 - 03.2018
Senior CRA
CROM (currently CROMSOURCE)
01.2011 - 04.2012
- I managed and executed assigned clinical studies on local level.
- I was the main point of contact for other local team members and for investigators in case of protocol-related or procedure-related questions.
- I trained and supervised other employees, monitored study sites, performed RA/EC submissions, etc.
- Positions:
- Country Clinical Research Coordinator/ Local PM 2006 to 2010
- Clinical Research Coordinator 2005 – 2006
- Clinical Trial Administrator 2004 – 2005
Education
MSc - Faculty of Pharmacy
Medical University in Warsaw
12.2001
Skills
- Capability of team building, also in a remote and/or cross cultural environment
- Excellent communication skills
- Capability of training and mentoring the staff
- Ability to build effective relationships with colleagues, clients, supervisors, investigators, etc
- Excellent problem-solving skills
- Ability to identify potential and real issues
- Excellent management skills, ability to present to senior management
- Ability to prioritize tasks
- Quality improvement
- Innovation and creativity
- Problem-solving abilities
Foreign languages
English - fluent (including medical vocabulary)
Spanish - good
German - good
Literature, ethnography, travelling, art (especially painting and music), psychology
Art- especially modern painting
Travelling- I like sightseeing in European capital cities; visited Helsinki in Apr this year
Music- especially world/ folk music
Travelling, art, music
- Travelling- I like sightseeing in European capital cities; visited Helsinki in Apr this year
- Art- especially modern painting
- Music- especially world/ folk music
Timeline
Clinical Team Manager
PPD, part of ThermoFisher Scientific
10.2021 - Current
Regional Clinical Trial Manager
DOCS (FSP for Amgen)
07.2020 - 09.2021
Country Manager and Project Manager
Navitas Life Sciences (previously EcronAcuNova)
04.2018 - 07.2020
Country Manager and Senior CRA
Navitas Life Sciences (previously EcronAcuNova)
04.2012 - 03.2018
Senior CRA
CROM (currently CROMSOURCE)
01.2011 - 04.2012
MSc - Faculty of Pharmacy
Medical University in Warsaw
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