IT within preclinical R&D, SEND development, evaluation and test of SEND software, SAS-programming, preparation of SEND compliant data for system testing

H Lundbeck A/S

SAS-programming
• Transforming raw data from clinical trials into the SDTM standard
• Software reengineering
• Ad-Hoc tasks
Change coordinator
• Change control and documentation of
• The SDTM data model
• The SDTM mapping table
• The Controlled Directory
Randomisation Administrator
• Randomisation and unblinding of clinical studies
• Delivery of randomisation data
• Responsible for the DNA code Keys

H Lundbeck A/S

SAS-programming
• creation of analysis datasets for clinical research
• creation of integrated databases
Randomisation Administrator
• Randomisation and unblinding of clinical studies
• Delivery of randomisation data
• Responsible for the DNA code Keys

Praktiska Broar

Master of Science in Engineering Physics

BioBridge Computing AB

Managed a team of five software engineers and one contractor.
Responsible for IT infrastructure at a company of ten people.
• Software Engineering in the fields of Proteomics and Biology
• Planning and coordination of Software Engineering activities
• Introduced weekly team meetings
• Introduced a change control process and connected forms
• Software, retrospective analysis
• Some C++ programming
• Some Configuration Management using CVS
• Software archeaology
• Integrated software into undocumentated systems using various programming languages, script languages, and operating systems
• Software retrospective documentation
• Systems and network administration and documentation
• Procurement of computer equipment, software and licences

Q-Labs

Software Engineering Consultant

Participated in internal training
• CMM
• CM
• Project Management (RUP)

Marketing
• Prepared tenders
• Prepared presentations
• Made cold calls to potential customers

AstraZeneca R&D

Provided for IT at an R&D department
• IT planning, coordination, and management
o Department IT-Budget
o Procurement
o Licences and maintenance agreements
o System evaluation at vendor sites
o Negotiation with vendors
o Network planning and management, RS/232, LAN using ethernet
o Facility management (computer room, switch room)
• System Management
o HP 1000, RTE-A
o VAX/VMS
o Misc Microsoft OS (DOS, LAN Manager, Windows*, ...)
o Data acquisition systems
o Lab data systems, LIMS, …
o Networking, RS/232, Ethetnet, DecNet, TCP/IP, …
o Programming, when needed to integrate systems
o Installation, configuration, roll-out, back-up, recovery, maintenance, documentation, …
o User management
• IT quality
o Quality documentation
o FDA regulations
o GLP
o System verification
o Participated in system validation
o Requirement specification
• User support
o Training and education
o Planning and coordination of training activities
o Troubleshooting
o Misc hands on
• Internal and external cooperation

Application Management
• Planning and coordination
• Cooperation with other sites
• Requirement management
• Scientific systems application management
• Application system configuration
• User training planning and coordination
• System documentation
• Vendor contacts
• System analysis
• System experience
o HPLC – Nelson 6000, Access*Chrom, AutoChrom
o LIMS – Sample Manager
o Biology – ActivityBase
o ChipTechnology/Microarrays – Affymetrix LIMS, GeneChip
Software Engineering processes
• Configuration Management – suppporting software development projects using VSS
• RUP introduction
• Requirement specifications

Military training Lv4