Clinical operations executive with extensive 20 years in country operations (medium - poland, large - germany market and corporate hqs - usa) experienced in 1) organization's development and build-up, 2) integrating clinops departments during merger and 3) Change Management focused on performance, output and quality. on top of this worked as a head of integrated medical department (clinops, regulatory, pv and medical affairs).
Risk Based Monitoring Central Capabilities Director
Since July 2017
global role accountable for establishing central Analytics function based on global data Operations and supporting risk based monitoring of company Clinical studies portfolio. mission: to enable merck’s risk based monitoring (rbm) approach by providing thoughtful quantitative Analysis of rbm tool data to more proactively identify risk and drive more efficient monitoring. Global role accountable for establishing Central Analytics function based on Global Data Operations and supporting Risk Based Monitoring of company clinical studies portfolio. Mission: To enable Merck’s Risk Based Monitoring (RBM) approach by providing thoughtful quantitative analysis of RBM Tool data to more proactively identify risk and drive more efficient monitoring.
Executive Director, Clinical Research, MSD GermanyJanuary 2014 --- June 2017
head of Clinical research operations department and Member of msd european Clinical operations Leadership team. management of up to 90 + msd and vendor staff and over 80 Clinical research projects. Change Management: 1. downsizing (-40% in 2014) and establishing flex sizing of the organization for future volatilities in pipelines work. buidling new team enriched with experience of newly acquired inlicensed employees. 2. Restructuring of some job functions to increase efficiency (e.g. submission, Finance start up functions). 3. mindset change of the team towards metrics driven high performance, goals achievement and quality. 4. establishing strong relationship with other msd departments, subsidiary management team, investigators. contacting other external partners (e.g.: German government/bundestag representatives) to highlight barriers slowing new studies placement in germany. 5. experience in interactions with works councils in cooperation with hr.
Chairman, Clinical Research Working GroupJuly 2010 --- December 2013
non-profit, pro bono activity focused on coordination of efforts of innovative Pharmaceutical Industry in ensuring improvement of acceptance and understanding of Clinical research in polish society, enabling dialogue with governmental decision makers and legislators in process of public consultations of new regulations governing Clinical trials, coordinating self-regulation effort of infarma members in scope of Clinical trials conduct to ensure standards improvement and maximization. this has been done through chairing and coordinating the work of infarma Clinical research working group in cooperation with infarma general Director, under the guidance of infarma management board as well as in cooperation with gcppl association board members. working group achievements: 1) implementation of code of conduct accepted by infarma management board, 2) successful participation in legislation consultations and ensuring important comments were voiced, 3) Education and presentation of Clinical research value (pricewaterhouse coopers report on Clinical trials), set-up of www.badaniaklinicznewpolsce.pl Clinical trials educational website listing all major trials conducted in poland by sponsors-members of infarma
Clinical Research Director, Global Clinical Trial Operations Lead, PolandFebruary 2010 --- December 2013
head of Clinical research in new merck (post merck and schering-plough merger). structuring and management of the post merger Clinical research organization combining 2 teams/work cultures. management of up to 50 direct/indirect reports and up to 60 trials (both insourced and outsourced). rotational (with medical affairs Director) chairmanship of medical governance council in msd poland
Regional Manager, Clinical OperationsJuly 2003 --- April 2005
merck hqs position (rahway, new jersey, usa) 1) supervision of Clinical research Operations in so called big 5 region in europe (germany, france, uk, italy, spain) 2) subsidiary interface project 3) development al assignment in preparation to Medical Director's position
Pharmaceutical representativeJanuary 1996 --- February 1997
LinkedIn Assessment :
MBA in business administration from Politechnika Warszawska in cooperation with London Business School/HEC in 1999
Medical Doctor in Medicine from Akademia Medyczna w Warszawie in 1994
in from Liceum im. Kopernika in 0000
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