Europa
Since Apr 2019, Nexus AG (Healthcare Software, 1300 MA), Irmastraße 1, D-78166 Donaueschingen
Project: Enhancement of a Hospital Information System
Feb 2019 Training for ITIL Foundation Certification in IT Service Management
Since Nov 2018, Abbvie (Pharma, Turnover: 28 Mrd. $), 67061 Ludwigshafen am Rhein
Project: IT Documentation for Oracle Apex Applications
Jan 2016 ? Aug 2018, Abbvie, Ludwigshafen, Germany
Project: Clinical Support Analyst & Validation Analyst
Oct 2015 ? Dec 2015, Robert Bosch GmbH, Stuttgart, Germany
Project: Technical specification of a Production Planning Tool
Feb 2015 ? Aug 2015, Oracle DBA, Primus Delphi Group, Warngau (München)
-Oracle11g &12c Database administration, installation, documentation (on Linux, Windows)
-Troubleshooting, e.g. for Dataguard, backup & recovery, database tuning
Jan 2013 ? Nov 2014, Support Lidl Stiftung, Neckarsulm, Germany
Project: Oracle Database 2nd & 3rd level support for international subsidiaries (acc. to ITIL)
->9000 instances of Oracle 10g & 11g Enterprise Edition (on MS Windows)
-Troubleshooting, e.g. for Dataguard, Oracle Streams
-Backup & recovery, database tuning
-Trainings given: SQL, PL/SQL, Oracle database administration
Sep 2012 ? Dec 2012, Robert Bosch GmbH, Stuttgart, Germany
Project: Development of planning tool for ?Unternehmensbereich KFZ?
-User requirements
-Technical specification
-Test plan creation, data modelling, documentation
Jan 2011 ? Aug 2012, Support Lidl Stiftung, Neckarsulm, Germany
Project: Oracle Database 2nd level support for international subsidiaries (acc. to ITIL)
->9000 instances of Oracle 10g Enterprise Edition (on MS Windows)
-Troubleshooting
-Backup & recovery, database tuning
-Database installation
-Trainings given: SQL, PL/SQL, Oracle database administration
Jul 2012 Helsana Versicherungen AG, Oracle Audit, Dübendorf, Switzerland
Project: Oracle Database Audit according to ISACA
-Audit of 30 Oracle instances
-Interview of responsible persons, DB querying, documentation review
-Volumne: 15 days
12/2011 Reporting of clinical data
-SQL query script creation for clinical data
-7 validated reports; 2 weeks
Nycomed, D-78467 Konstanz
01/2011 - 02/2012 Oracle Database Support (1st and 2nd Level)
~10.000 instances Oracle 10g EE
-Troubleshooting
-Backup and recovery, installation
-Trainer for SQL and Database Administration
LIDL Stiftung & Co. KG, D-74167 Neckarsulm
06/2010 - 12/2010 Database Remote Administration Oracle 9i / 10g (monthly)
5 Oracle instances
·Alert-log and backup check
·Storage usage and forecast
·Troubleshooting and tuning (if needed)
·GMP compliant report
Solvias AG, CH-4002 Basel
10/2010 Analysis of Oracle Clinical data
·Analysis of data structure and data
·Data import into Oracle
·Data modell analyse with Enterprise Architect
wega Informatik, CH-4051 Basel
07/2010 Proprietary Oracle 11g Standby Database
·Creation of an Oracle Standby Database on Linux
·Standby recovery functionality via proprietary scripts
·Base: Oracle 11g Standard Edition
wega Informatik, CH-4051 Basel
06/2010 Test case check for a Clinical EDC-System
·GCP relevant, commercial EDC-System
·Mapping of system manual features and test cases
·Check of completeness, test volume and test case description
Dörnen Systemtechnik, D-79540 Lörrach
09/2009 - 01/2010 Software Validation Expert
·Check of validation documentation (V-model) for a
clinical database including subsystems
·Extent: approx. 70 home grown GCP-relevant IT-systems
·Reporting: Validation approach, validation gaps, measurements
Nycomed GmbH (ex ALTANA Pharma AG), D-78467 Konstanz
10/2009 Troubleshooting Oracle Replication
·Bug fixing for a replication system via materialized views
·Verification of the 'fast refresh' mechanism
·Conversion from incremental to full backup
·Downsizing of the TBS SYSAUX (too much statistical data)
COMSOFT GmbH, Wachhausstr. 5a, D-76227 Karlsruhe
09/2009 Oracle 11g Admin-Workshop (2 days)
·Tablespace, storage management
·Materialized Views
·Backup strategies, RMAN
·Block Change Tracking, Flash Recovery Area
·Automatic Workload Repository
COMSOFT GmbH, Wachhausstr. 5a, D-76227 Karlsruhe
Former Employments
01/2008 ? 07/2009 Oracle Consulting Manager and Database Administrator
(Dismissal because of economic situation)
Hunkler GmbH und Co. KG, D-78315 Radolfzell
·Remote administration of numerous customer databases
·Troubleshooting, tuning, backup & recovery; Windows, Linux, Unix
·Workshops: Oracle 10g Administration, OEM, SQL, PL/SQL
·Database concepts, process optimisation
·Team leader Oracle consulting
·Managing Oracle service requests (Oracle MetaLink)
10/2007 - 12/2007 Hive-off vehicle after take-over of ALTANA Pharma by Nycomed and massive reduction of staff
08/2001 - 09/2007 Oracle Database Developer (Clinical Database Management)
Nycomed GmbH (ex ALTANA Pharma AG), D-78467 Konstanz
03/2006 Promotion: Senior Group Leader
01/2004 Promotion: Group Leader Clinical Database Management
·Manager for ClinDB (Clinical database)
·SQL, PL/SQL, Developer Forms, Oracle Designer, Reports
·Application Programming, data modelling
·Maintenance of the data model and clinical applications
·Project lead: Retrospective validation of clinical IT-systems; Extent: ~ 4 full time equivalent
·Process optimisation
·Writing of SOPs and guidelines
·Software validation according to V-model
·>40 trainings hold: SQL, PL/SQL, SQL Navigator, Excel
·1st and 2nd level support for users
·Team leader: 8 database developer
01/2001 - 06/2001 Oracle Database Administrator (Dismissal due to insolvency)
living systems AG, D-78166 Donaueschingen
·DB administration on NT, Linux, Sun Solaris: ~50 instances
·Installation, backup and recovery, tuning
·Data modelling, developer support
·Developer trainings: SQL (Deutsch / English)
03/2000 - 12/2000 Oracle 8i Database Administrator qualification
04/1992 - 02/2000 Product management and sales in the field of medical optics
06/1986 - 03/1992 Studum der Physik, Christian-Albrechts-Universität Kiel, Germany
Abschluss als Diplom-Physiker
03/2000 - 12/2000 Qualifikation zum Oracle 8i Datenbankadministrator
ptm-Akademie, D-80336 München
Programmierung: SQL, PL/SQL, JAVA
Administration: Installation, Konfiguration, Backup & Recovery, Tuning, Net8i
Datenbanken: Oracle 8i, MS SQL-Server, ACCESS
Betriebssysteme: Windows 98, NT Server, Linux / Unix
Abschluss als OCP DBA 8i
IT-Trainings (participation)
10/2001 Introduction: Oracle Forms Developer 6i (Fa. Trivadis)
02/2002 Introduction: XML and ORACLE XML (Fa. Trivadis)
04/2002 Designer Middle Case (Fa. Trivadis)
05/2002 SAS-NT: Environment + Editor
09/2002 Oracle 9i Release 2 (Fa. Trivadis)
09/2003 Introduction: Project Management Fundamentals (Accenture)
10/2003 Multi Project Management System (MPMS) Training
11/2002 Oracle Forms Developer 6i Advanced (Fa. Trivadis)
10/2003 Multi Project Mgmt: Function Specific User Training for Primavera P3e (Accenture)
12/2003 Multi Project Mgmt: Resource Mgmt User Training for Primavera P3e (Accenture)
10/2005 Workgroup Database for IT-VMP
10/2005 Managing Projects (School of Business, Washington, D.C)
05/2006 Introduction: BDSG – data privacy and protection
06/2006 Information Security Training (ALTANA in-house)
07/2006 eSmile Incident Management
10/2006 Managing Projects (School of Business, Washington, D.C)
11/2006 Managing Projects: Scheduling & Cost Control (School of Business, Wash., D.C)
07/2007 Java for Oracle Developers (Fa. Trivadis)
01/2007 Oracle Reports (Fa. Trivadis)
08/2007 Oracle Database 10g: New Features for Oracle 8i DBAs (Oracle)
06/2009 Oracle Apex Workshop (Oracle)
10/2009 Basics of Network Technology (VHS)
10/2009 Basics of Linux Administration (bodenseo)
11/2009 Workstation Administration: Windows XP / Vista (VHS)
11/2009 Server Administration: Windows 2003 Server (VHS)
01/2010 Linux Administration (VHS)
02/2010 Access 2003: VBA-Programming and Automatisation (VHS)
03/2010 Introduction: SAP R/3 (VHS)
05/2010 End-To-End CDM efficiency - from eCRF set-up to submission & archival (xClinical)
Validation Trainings (participation)
06/2003 Validation of Computer Systems Pharmaceutical Manufacturing (CFPA Amsterdam)
06/2003 Claims of the FDA related to 21 CFR Part 11
06/2003 Claims of the FDA related to 21 CFR Part 11 Upgrade
06/2003 Computerized Systems in Clinical Trials Introduction
09/2003 IT-Regulations for the Pharmaceutical Industry
01/2004 Quality Control of clinical documents
01/2004 Archiving GCP-GLP relevant documents
01/2004 Source data verification
04/2004 SDLC Project documentation
05/2004 Medical and Scientific Writing (Mediwrite)
02/2005 Handling of Case Report Forms in Clinical Data Management
02/2005 Handling of Emergency-Cards
04/2005 Computer System Validation based on ALTANA Guidelines for IT Project Manager
07/2006 Development of CDISC SDTM Generators
07/2006 Quality Policy
09/2006 Computerized Systems Used In Clinical Trial
10/2006 New Trends in Computer Systems Validation (Scott tiger)
10/2006 What is the best practice in computer system validation (Scott tiger)
10/2006 Oracle User Expert Forum (Scott tiger)
04/2007 Introduction: Biometric planning and analysis if clinical trials
05/2007 CSV- Risk Management
06/2007 Electronic Signatures
09/2007 IT-Compliance in 21 steps
05/2010 Computer System Validation (JSB Validierung)
Support, Oracle, DBA, Apex, PL/SQL, SQL, GxP, GCP, FDA, 21CFR Part 11, SDLC, Validierung, GAMP, ITIL Certification (ITSM)
Oracle Database Administration
> 15 years experience
Triple OCP (8i, 10g, 11g)
Installation, Administration, Backup and Recovery, Tuning, Database Concepts
Oracle Database Programming
> 6 years experience in database programming
SQL, PL/SQL, Oracle Forms, Oracle Designer
Validation of GxP-relevant Software (according to GAMP)
> 6 years experience in a pharmaceutical company
Project Manager Retrospective Validation (~4 FTE), GxP, GCP, 21 CFR Part 11, GAMP
Oracle Trainings
> 50 Oracle trainings
SQL, PL/SQL, Oracle DBA, SQL Navigator, DB Tuning
Certifications
Oracle Certified Professional DBA 11g
Oracle DB 10g: Managing Oracle on Linux Certified Expert
Oracle Enterprise Linux Certified Implementation Specialist
IT-Network Technician (IHK)
Oracle Certified Professional DBA 10g
Oracle PL/SQL Developer Certified Associate
Oracle Certified Professional DBA 8i
GCP
GAMP
21 CFR Part 11
V-Modell
GXP
FDA
Pharma, Chemie, IT, Industrie, Handel, Automobilzulieferer, Energieversorger, Einzelhandel
Europa
Since Apr 2019, Nexus AG (Healthcare Software, 1300 MA), Irmastraße 1, D-78166 Donaueschingen
Project: Enhancement of a Hospital Information System
Feb 2019 Training for ITIL Foundation Certification in IT Service Management
Since Nov 2018, Abbvie (Pharma, Turnover: 28 Mrd. $), 67061 Ludwigshafen am Rhein
Project: IT Documentation for Oracle Apex Applications
Jan 2016 ? Aug 2018, Abbvie, Ludwigshafen, Germany
Project: Clinical Support Analyst & Validation Analyst
Oct 2015 ? Dec 2015, Robert Bosch GmbH, Stuttgart, Germany
Project: Technical specification of a Production Planning Tool
Feb 2015 ? Aug 2015, Oracle DBA, Primus Delphi Group, Warngau (München)
-Oracle11g &12c Database administration, installation, documentation (on Linux, Windows)
-Troubleshooting, e.g. for Dataguard, backup & recovery, database tuning
Jan 2013 ? Nov 2014, Support Lidl Stiftung, Neckarsulm, Germany
Project: Oracle Database 2nd & 3rd level support for international subsidiaries (acc. to ITIL)
->9000 instances of Oracle 10g & 11g Enterprise Edition (on MS Windows)
-Troubleshooting, e.g. for Dataguard, Oracle Streams
-Backup & recovery, database tuning
-Trainings given: SQL, PL/SQL, Oracle database administration
Sep 2012 ? Dec 2012, Robert Bosch GmbH, Stuttgart, Germany
Project: Development of planning tool for ?Unternehmensbereich KFZ?
-User requirements
-Technical specification
-Test plan creation, data modelling, documentation
Jan 2011 ? Aug 2012, Support Lidl Stiftung, Neckarsulm, Germany
Project: Oracle Database 2nd level support for international subsidiaries (acc. to ITIL)
->9000 instances of Oracle 10g Enterprise Edition (on MS Windows)
-Troubleshooting
-Backup & recovery, database tuning
-Database installation
-Trainings given: SQL, PL/SQL, Oracle database administration
Jul 2012 Helsana Versicherungen AG, Oracle Audit, Dübendorf, Switzerland
Project: Oracle Database Audit according to ISACA
-Audit of 30 Oracle instances
-Interview of responsible persons, DB querying, documentation review
-Volumne: 15 days
12/2011 Reporting of clinical data
-SQL query script creation for clinical data
-7 validated reports; 2 weeks
Nycomed, D-78467 Konstanz
01/2011 - 02/2012 Oracle Database Support (1st and 2nd Level)
~10.000 instances Oracle 10g EE
-Troubleshooting
-Backup and recovery, installation
-Trainer for SQL and Database Administration
LIDL Stiftung & Co. KG, D-74167 Neckarsulm
06/2010 - 12/2010 Database Remote Administration Oracle 9i / 10g (monthly)
5 Oracle instances
·Alert-log and backup check
·Storage usage and forecast
·Troubleshooting and tuning (if needed)
·GMP compliant report
Solvias AG, CH-4002 Basel
10/2010 Analysis of Oracle Clinical data
·Analysis of data structure and data
·Data import into Oracle
·Data modell analyse with Enterprise Architect
wega Informatik, CH-4051 Basel
07/2010 Proprietary Oracle 11g Standby Database
·Creation of an Oracle Standby Database on Linux
·Standby recovery functionality via proprietary scripts
·Base: Oracle 11g Standard Edition
wega Informatik, CH-4051 Basel
06/2010 Test case check for a Clinical EDC-System
·GCP relevant, commercial EDC-System
·Mapping of system manual features and test cases
·Check of completeness, test volume and test case description
Dörnen Systemtechnik, D-79540 Lörrach
09/2009 - 01/2010 Software Validation Expert
·Check of validation documentation (V-model) for a
clinical database including subsystems
·Extent: approx. 70 home grown GCP-relevant IT-systems
·Reporting: Validation approach, validation gaps, measurements
Nycomed GmbH (ex ALTANA Pharma AG), D-78467 Konstanz
10/2009 Troubleshooting Oracle Replication
·Bug fixing for a replication system via materialized views
·Verification of the 'fast refresh' mechanism
·Conversion from incremental to full backup
·Downsizing of the TBS SYSAUX (too much statistical data)
COMSOFT GmbH, Wachhausstr. 5a, D-76227 Karlsruhe
09/2009 Oracle 11g Admin-Workshop (2 days)
·Tablespace, storage management
·Materialized Views
·Backup strategies, RMAN
·Block Change Tracking, Flash Recovery Area
·Automatic Workload Repository
COMSOFT GmbH, Wachhausstr. 5a, D-76227 Karlsruhe
Former Employments
01/2008 ? 07/2009 Oracle Consulting Manager and Database Administrator
(Dismissal because of economic situation)
Hunkler GmbH und Co. KG, D-78315 Radolfzell
·Remote administration of numerous customer databases
·Troubleshooting, tuning, backup & recovery; Windows, Linux, Unix
·Workshops: Oracle 10g Administration, OEM, SQL, PL/SQL
·Database concepts, process optimisation
·Team leader Oracle consulting
·Managing Oracle service requests (Oracle MetaLink)
10/2007 - 12/2007 Hive-off vehicle after take-over of ALTANA Pharma by Nycomed and massive reduction of staff
08/2001 - 09/2007 Oracle Database Developer (Clinical Database Management)
Nycomed GmbH (ex ALTANA Pharma AG), D-78467 Konstanz
03/2006 Promotion: Senior Group Leader
01/2004 Promotion: Group Leader Clinical Database Management
·Manager for ClinDB (Clinical database)
·SQL, PL/SQL, Developer Forms, Oracle Designer, Reports
·Application Programming, data modelling
·Maintenance of the data model and clinical applications
·Project lead: Retrospective validation of clinical IT-systems; Extent: ~ 4 full time equivalent
·Process optimisation
·Writing of SOPs and guidelines
·Software validation according to V-model
·>40 trainings hold: SQL, PL/SQL, SQL Navigator, Excel
·1st and 2nd level support for users
·Team leader: 8 database developer
01/2001 - 06/2001 Oracle Database Administrator (Dismissal due to insolvency)
living systems AG, D-78166 Donaueschingen
·DB administration on NT, Linux, Sun Solaris: ~50 instances
·Installation, backup and recovery, tuning
·Data modelling, developer support
·Developer trainings: SQL (Deutsch / English)
03/2000 - 12/2000 Oracle 8i Database Administrator qualification
04/1992 - 02/2000 Product management and sales in the field of medical optics
06/1986 - 03/1992 Studum der Physik, Christian-Albrechts-Universität Kiel, Germany
Abschluss als Diplom-Physiker
03/2000 - 12/2000 Qualifikation zum Oracle 8i Datenbankadministrator
ptm-Akademie, D-80336 München
Programmierung: SQL, PL/SQL, JAVA
Administration: Installation, Konfiguration, Backup & Recovery, Tuning, Net8i
Datenbanken: Oracle 8i, MS SQL-Server, ACCESS
Betriebssysteme: Windows 98, NT Server, Linux / Unix
Abschluss als OCP DBA 8i
IT-Trainings (participation)
10/2001 Introduction: Oracle Forms Developer 6i (Fa. Trivadis)
02/2002 Introduction: XML and ORACLE XML (Fa. Trivadis)
04/2002 Designer Middle Case (Fa. Trivadis)
05/2002 SAS-NT: Environment + Editor
09/2002 Oracle 9i Release 2 (Fa. Trivadis)
09/2003 Introduction: Project Management Fundamentals (Accenture)
10/2003 Multi Project Management System (MPMS) Training
11/2002 Oracle Forms Developer 6i Advanced (Fa. Trivadis)
10/2003 Multi Project Mgmt: Function Specific User Training for Primavera P3e (Accenture)
12/2003 Multi Project Mgmt: Resource Mgmt User Training for Primavera P3e (Accenture)
10/2005 Workgroup Database for IT-VMP
10/2005 Managing Projects (School of Business, Washington, D.C)
05/2006 Introduction: BDSG – data privacy and protection
06/2006 Information Security Training (ALTANA in-house)
07/2006 eSmile Incident Management
10/2006 Managing Projects (School of Business, Washington, D.C)
11/2006 Managing Projects: Scheduling & Cost Control (School of Business, Wash., D.C)
07/2007 Java for Oracle Developers (Fa. Trivadis)
01/2007 Oracle Reports (Fa. Trivadis)
08/2007 Oracle Database 10g: New Features for Oracle 8i DBAs (Oracle)
06/2009 Oracle Apex Workshop (Oracle)
10/2009 Basics of Network Technology (VHS)
10/2009 Basics of Linux Administration (bodenseo)
11/2009 Workstation Administration: Windows XP / Vista (VHS)
11/2009 Server Administration: Windows 2003 Server (VHS)
01/2010 Linux Administration (VHS)
02/2010 Access 2003: VBA-Programming and Automatisation (VHS)
03/2010 Introduction: SAP R/3 (VHS)
05/2010 End-To-End CDM efficiency - from eCRF set-up to submission & archival (xClinical)
Validation Trainings (participation)
06/2003 Validation of Computer Systems Pharmaceutical Manufacturing (CFPA Amsterdam)
06/2003 Claims of the FDA related to 21 CFR Part 11
06/2003 Claims of the FDA related to 21 CFR Part 11 Upgrade
06/2003 Computerized Systems in Clinical Trials Introduction
09/2003 IT-Regulations for the Pharmaceutical Industry
01/2004 Quality Control of clinical documents
01/2004 Archiving GCP-GLP relevant documents
01/2004 Source data verification
04/2004 SDLC Project documentation
05/2004 Medical and Scientific Writing (Mediwrite)
02/2005 Handling of Case Report Forms in Clinical Data Management
02/2005 Handling of Emergency-Cards
04/2005 Computer System Validation based on ALTANA Guidelines for IT Project Manager
07/2006 Development of CDISC SDTM Generators
07/2006 Quality Policy
09/2006 Computerized Systems Used In Clinical Trial
10/2006 New Trends in Computer Systems Validation (Scott tiger)
10/2006 What is the best practice in computer system validation (Scott tiger)
10/2006 Oracle User Expert Forum (Scott tiger)
04/2007 Introduction: Biometric planning and analysis if clinical trials
05/2007 CSV- Risk Management
06/2007 Electronic Signatures
09/2007 IT-Compliance in 21 steps
05/2010 Computer System Validation (JSB Validierung)
Support, Oracle, DBA, Apex, PL/SQL, SQL, GxP, GCP, FDA, 21CFR Part 11, SDLC, Validierung, GAMP, ITIL Certification (ITSM)
Oracle Database Administration
> 15 years experience
Triple OCP (8i, 10g, 11g)
Installation, Administration, Backup and Recovery, Tuning, Database Concepts
Oracle Database Programming
> 6 years experience in database programming
SQL, PL/SQL, Oracle Forms, Oracle Designer
Validation of GxP-relevant Software (according to GAMP)
> 6 years experience in a pharmaceutical company
Project Manager Retrospective Validation (~4 FTE), GxP, GCP, 21 CFR Part 11, GAMP
Oracle Trainings
> 50 Oracle trainings
SQL, PL/SQL, Oracle DBA, SQL Navigator, DB Tuning
Certifications
Oracle Certified Professional DBA 11g
Oracle DB 10g: Managing Oracle on Linux Certified Expert
Oracle Enterprise Linux Certified Implementation Specialist
IT-Network Technician (IHK)
Oracle Certified Professional DBA 10g
Oracle PL/SQL Developer Certified Associate
Oracle Certified Professional DBA 8i
GCP
GAMP
21 CFR Part 11
V-Modell
GXP
FDA
Pharma, Chemie, IT, Industrie, Handel, Automobilzulieferer, Energieversorger, Einzelhandel