Experience

NOCC Prague

• Czechia
• Financial Services
• 1 - 100 Employee

• Regional Category Manager - Europe , Medical

  • Nov 2020 - Present

  To provide cross divisional regional (Europe) category leadership to deliver measurable value for Novartis. To own the cross divisional regional category strategy for services and activities to support country Medical Affairs in Region Europe and related sub-categories to leverage Novartis scale and position in the market. To embed & deliver the regional category strategy via close alignment with the global category strategy and engagement with country business stakeholders. Selecting and managing major, preferred suppliers. Responsible for close collaboration with the Global Category Managers to co-determinate and implement global procurement strategies of the category. Responsible for stakeholder management: Care and development of relationships to internal and external partners, positioning as competent advisor, e.g. regarding assessment of needs, purchasing of services and especially regarding approaches for improvement during and after the completion of projects. Responsible for leadership of / cooperation in cross-functional and cross-divisional of European and global (partial) projects. Responsible for leadership of team of Clinical Sourcing Managers to support allocated European countries in tender process, RFP negotiations and contracting of relevant suppliers in Medical Affairs specific services. Accountable for the overall delivery of the category savings targets for all Divisions within the countries of Region Europe following the target setting process. Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Country Category Manager, Medical

  • Oct 2015 - Nov 2020

  To provide cross divisional country category leadership to deliver measurable value for Novartis. To own the cross divisional country category strategy for services and activities to support country Medical Affairs and related sub-categories to leverage Novartis scale and position in the market. To embed & deliver the country category strategy via close alignment with the global category strategy and engagement with business stakeholders. Selecting and managing major, preferred suppliers. Responsible for close collaboration with the Global Category Managers to co-determinate and implement global procurement strategies of the category. Responsible for stakeholder management: Care and development of relationships to internal and external partners, positioning as competent advisor, e.g. regarding assessment of needs, purchasing of services and especially regarding approaches for improvement during and after the completion of projects. Responsible for leadership of / cooperation in cross-functional and cross-divisional German, European and global (partial) projects. Accountable for the overall delivery of the category savings targets for all Divisions within the CPO following the target setting process. Show less

• Strategic Sourcing Manager

  • Mar 2014 - Sep 2015

  Medical SourcingResponsible for local spent in assigned categories. Close cooperation with internal business partners to achieve cost savings and process improvements. Performs category management with respect to vendor selection, contract negotiation and contract execution of master service agreements. Development of a pool of external service providers in accordance with medical sourcing strategy. Supporting process of vendor qualification. Consulting the internal business partners in demand management and responsible procurement. Business-partnering and stakeholder management. Cross-functional and cross-divisional cooperation in assigned projects. Acting as subject matter experts in data management services. Show less

• Manager, CRO Management and Contracting

  • Sep 2012 - Mar 2014

  Responsible for functional supervision of a team of allocated clinical contract administrators and CRO contracting specialists.Responsible for developing standardized Master Service Agreements and Task Order templates for clinical contracting in cooperation with legal and functional departments as appropriate.Supervision and evaluation of CRO Performance on assigned projects.Support of functional departments during process of vendor qualification.Support of medical sourcing during contract negotiation and contract execution process of Master Service Agreements.Responsible for in time delivery of executed clinical contracts for allocated projects to CROs.Development of standardized templates for clinical site contracts in cooperation with legal and functional departments and escalation of deviation from standard contract to ensure in time execution of site contract. Show less

• Specialist Contracting CRO Management

  • Jan 2012 - Aug 2012

  Preparation and execution of task orders with CROs (Contract Research Organization) for interventional and non-interventional trials. Responsible for leading the contract negotiation. Involved in ongoing evaluation of CRO market and selection of preferred vendors. Monitoring of CRO performance, risk escalation and resources.



PPD

• United States
• Research Services
• 700 & Above Employee

• Manager, Clinical Data Management

  • Apr 2006 - Dec 2011

  Provides supervisory functions for a team of allocated staff within the Clinical Data Management department including training and mentoring. Supports HR and Clinical Data Management senior management with the hiring and development of Clinical Data Management personnel. Allocates clear responsibilities within the Clinical Data Management team for each assigned project to enable all targets to be met. Ensures that all data management activities are conducted in line with regulatory guidelines, global Standard Operating Procedures (SOPs), and client expectations. Participates in the development and implementation of processes, procedures and training for the Clinical Data Management function. Show less

• Clinical Data Manager

  • Apr 2003 - Mar 2006

  Acts as a Lead Clinical Data Manager for one or more projects, or provides support to the Lead Clinical Data Manager for one or more projects. Liaises with clients and colleagues in other functional groups as required. Fulfils all data management cleaning activities in accordance with the Data Validation Manual (DVM) and/or client documentation. Designates tasks appropriately within the team ensuring all work conducted is completed to the acceptable quality in accordance with global Standard Operating Procedures (SOPs) and the DVM. Represents Clinical Data Management at internal and external meetings and presentations. Supports the training team as a Subject Matter Expert and/or assessment reviewer. Show less

• Senior Clinical Data Associate

  • Oct 2002 - Mar 2003

  Performs checks on the clinical data in accordance with the study specific guidelines to ensure its validity. Performs quality control activities and ensures all necessary documentation is created and filed correctly. Participates in the creation of study documentation. Supports the training team as a Subject Matter Expert and/or competency reviewer and participates in process improvements. Performs Lead CDA role for small studies or specific areas of large studies.

• Clinical Data Associate

  • Apr 2002 - Sep 2002

  Supports the set up of study activities such as CRF design, database design, including testing of data entry screens, and Data Validation Manual (DVM) creation, as required. Fulfils all data management cleaning activities in accordance with the DVM and/or client documentation. Performs quality control activities as defined in the DVM and ensures all necessary documentation is created and filed correctly. Supports the training team as a Subject Matter Expert and/or assessment reviewer.



Pharmacia

• Erlangen und Umgebung, Deutschland

• Clinical Research Assistant (CRA)

  • Mar 2000 - Mar 2002

  Experience as Project Manager and monitor for post-marketing studies in growth hormone treatment for children and adolescents at Endokrinology & Metabolism unit of Pharmacia. Involved in many aspects of study set-up, data management, investigator liaison and internal reporting. Experience as Project Manager and monitor for post-marketing studies in growth hormone treatment for children and adolescents at Endokrinology & Metabolism unit of Pharmacia. Involved in many aspects of study set-up, data management, investigator liaison and internal reporting.



Pharmacia&Upjohn

• Erlangen und Umgebung, Deutschland

• Clinical Trial Assistant

  • Sep 1997 - Feb 2000

  Clinical Trial Assistant at Endokrinology & Metabolism unit of Pharmacia & Upjohn GmbH Clinical Trial Assistant at Endokrinology & Metabolism unit of Pharmacia & Upjohn GmbH



FAU Erlangen-Nürnberg

• Germany
• Research Services
• 700 & Above Employee

• Research Assistant

  • Mar 1997 - Feb 2000

  Research Assistant in Biochemistry at Lehrstuhl für Biochemie. Research work in fatty acid metabolism in yeast. Supervising activities for students. Research Assistant in Biochemistry at Lehrstuhl für Biochemie. Research work in fatty acid metabolism in yeast. Supervising activities for students.