Global Program Manager-Veeva R&D-Serialization SAP ATTP ICH Tracelink-PMO Management- Professional SCRUM Product Owner-Scrum Master-SAFe-PRINCE2-ITIL
Aktualisiert am 05.10.2023
Freiberufler / Selbstständiger
Verfügbar ab: 05.10.2023
Verfügbar zu: 100%
davon vor Ort: 10%
Large Scale Projects
Cross-Functional Management
Regulatory Compliance
Software Quality Assurance
Agile Methodologies
Digital Strategy
PMO Support
Veeva R&D
SAP Serialization
CMC development
Scrum Master
Scrum Product Owner


Copenhagen (+50km)


1 Jahr
2022-06 - 2023-05

Global Track & Trace Serialization implementation.

Senior Project Manager agiles Projektmanagement
Senior Project Manager

Project Manager of implementing end-2-end Serialization Track & Trace solution in the Middle East region for UAE and Bahrain. 

Scope covered change management for the Serialized Supply Chain, assuring Regulatory Compliance, Master Data change, SAP ATTP and ICH development, setup and validation of Tracelink, SAP ATTP and ICH integration with local 3PL and distributor for reporting on behalf of MAH to authorities, Cross organizational OCM including SOP and Training. 

Parallel to implementation, CMO and 3PL partners were onboarded and integrated in the Data Process Flow to TraceLink. 

Countries and Authorities in scope: 

  • UAE MOHAP & Tatmeen 
  • Bahrain National Health Regulatory Authority

Cross Functional Management SAP Serialization Track & Trace CSV
agiles Projektmanagement
3 Jahre 10 Monate
2018-07 - 2022-04

Veeva R&D global IT system implementation and data migration

Senior Program Manager RIM eTMF QMS ...
Senior Program Manager

Global Veeva R&D system implementation

Project Manager and OCM Lead of implementing the Veeva R&D suite of Vaults globally.

The projects also scoped 2 large parallel data migrations from legacy systems into Veeva Vault RIM and Quality Docs.

This strategic program started in 2018 by scoping the investment with focus on management of stakeholder expectations. By implementing Veeva systems it streamlined internal processes and enabled the connection, tracking, monitoring, archiving and notification of one source of data across the organization. It also improved management oversight, trending, reporting, in addition to position Bavarian Nordic as one of the largest pure play vaccines companies.

Vaults implemented: RIM, eTMF, QMS, Quality Docs, Vault Training, Station Manager.

CMC product development for MVA-BN-TAEK-VAC vaccine.

Head of leading the CMC project Phase1 from early development to TOX studies and

production towards IND filing.

Implementing new Stage Gate Model for entry of new CMC products and new PPM tool

Responsible for implementing and developing the PMO project Stage Gate Model to

facilitate the pipeline and production of new vaccines for cancer and infectious diseases.

Development and Implementation of functional PPM system, (Milestone plans, Governance model, resource plans, risk analysis and reporting).

Veeva R&D
RIM eTMF QMS Quality Docs Vault Training Station Manager.
Bavarian Nordic
8 Jahre 10 Monate
2009-09 - 2018-06

Various Projects

Project Manager
Project Manager
?VEU godtgørelse" SAP development for ?Arbejdsgivernes Uddannelsesbidrag? AUB
Project Manager for internal IT development and implementation system to handle the
Danish law for VEU compensation (Part of the Danish 3 Parts agreement) The assignment was managed for the Ministry of Education and the Danish Agency for IT
and Learning ? STIL. The Processing Business System was developed on the ATP SAP
platform and domains. The system was designed to disburse about DKK one billion
annually to approximate 200,000 payouts to employees or their employer.

TPC DKK 12 million 

Agile Project team 10 full time ? and several part time project members.

Product owner/ Project Manager for new IT system implementation for Sygedagpengeforsikring and Tjenestemandspension

The Assignment was part of the Government initiative ?Bedre Balance? and implies that
Statens Administrations Finansservicecenters (FSC) was transferred over to Udbetaling
Danmark. The system called SFO is administered by Udbetaling Danmark for the Agency
for Modernisation Ministry of Finance. TPC 90 million total for SFO renewal.
Sygedagpengeforsikring and Tjenestemandspensions is estimated to DKK 25 million.

Productowner / Project Manager for development and implementation of the Danish

law ?jobpræmieordningen" 

for financial support to long term unemployed Citizens. The assignment is managed for the Ministry of Employment and the Danish Agency for Labour Market and Recruitment ? STAR. The Processing Business System is developed on the ATP?s platform and to disburse about DKK 540 million annually to average 25.000 persons in payment to the Danish unemployed on social assistance. TPC DKK 30 million incl. 3 years operations (TPC development DKK 10 million) 

Agile Project team 10 full time ? 55 part time project members.

Project Manager for RFI/RFP procurement of the new Robotics Process Automation

solution software
Identification and analyze the needs to keep up the automation of manual rules based
back office administrative processes. The system reducing cost and improving accuracy by creating a digital workforce. The project included the process and management within the ATP governed framework and operating model. TPC DKK 5 million. Project team 10 full time project members.

Project Manager for development and implementation of ?NemSMS? 

to the Processing Business Systems as Feriekonto, Lønmodtagernes Garantifond, ATP Livslang Pension and Kontanthjælpsloftet/Særlig Støtte. The text system is based on standards Text services for Danish central government, partners and organizations. The system is designed as full automatically and it is generating over 1 million text service to Danish Citizens per year. TPC DKK 8 million. Project team 5 full time ? 20 part time project members.

Project Manager for implementing Digital Post version 2.0 for ATP & Udbetaling


System integration and implementation of the mandatory Digital Post from public authorities. The Danish Public Digital Post Act gives ATP and Udbetaling Danmark

the right to send digital-only messages, letters, documents, etc. to citizens and businesses as Digital Post, rather than sending paper-based letters by traditional post.
TPC DDK 4 million. Project team 10 part time project members.

Project Manager for development and implementation of Test Automation for regression testing 

to all the Processing Business System that is managed and administered at ATP. Identification and analyze the needs to develop the automation of tests. In ATP it is very

cost-effective to regression testing of all our software products and Processing Business
Systems that have a long maintenance life. In ATP we have several major and minor releases over the year. By identifying areas for automated test we increased test coverage, improves accuracy, and saved time and money in comparison to manual testing. TPC DKK 8 million. Project team 5 full time ? 10 part time project members.

Project Manager for several IT development and infrastructure transition projects 

for and towards ATPs sourcing partners (KMD, NetCompany, NNIT) Sungard investment system implementation in the Pension Investment department for unlisted assets.

Development of new print strategy Mainframe program exit SW Release process implementation with Sourcing partner Several IT technical projects eg. Content Manager, On demand, ITSM web services, Websphere MQ, DB2, IBM Content Manager z/OS, IBM TFIM, Single sign on / Password Sync. IBM Tivoli, G/On, Citrix, ClearCase, ClearQuest

Aus- und Weiterbildung


2018 - 2018
  • Agile Product Owner Professional Scrum Product Owner certified

2017 - 2017

  • Agile SCRUM Professional Scrum Master certified

2010 - 2011

  • IPMA Project Management certified

2010 - 2010

  • PRINCE 2 Foundation certified
  • ITIL Foundation v. 3 certified
  • Test management certified (ATP internal course)

2003 - 2003

  • HD 1. part CBS

1986 - 1987

  • HH, Niels Brock

Research and ongoing training

2020 - 2020

  • Appreciative and Empathic Communication, Gitte Brandenburg Carlsen, Teknologisk Institut
  • GDP practice and course, Camilla Lundbye Castle, Tina Brouer, Pharmakon

2018 - 2018

  • GMP for IT responsible. Validation and operation of computer systems subject to GMP, Anders Vidstrup, Pharmakon
  • SAFe Agil development
  • Drawing promotes understanding - graphical facilitation, Katrine Raae Søndergaard, Implement Consulting Group

2016 - 2016

  • Feedback and communication training towards the project team, Dorte Høyer Adamsen, psychologist
  • Automation and Customer Journey, Søren Finsel Bisgaard , Vice President, Group Process development, Danske Bank

2015 - 2015

  • Management and Motivation of Knowledgeworker, Senior researcher Helle Hedegaard Hein, Cand Merc and ph.D, CBS

2014 - 2014

  • Positive Psychology by cand.psych. Lars Ginnerup, awarded Professor at CBS
  • Targeted optimization of network and stakeholder - use your network optimally by Susie Lynge, Netværksakademiet
  • High Performance Team by ATP internal

2013 - 2013

  • Agile Project Management by ATP internal
  • Hogan Assessment personality test. Development of my leadership skills ongoing
  • Project Managers role in creating motivation by Henrik Bjørnstrup from Bjørnstrup partners
  • Project Leadership Profile 360° and 6 Leadership Styles by Mannaz
  • Project management engagement and role in contract negotiation by Lawyer Søren Skibsted, Kromann Reumert

2002 - 2009

  • Ongoing relevant IT management, strategy sales and presentation training

2007 - 2007

  • Training in profitability, earnings, valuations

2003 - 2003

  • Media training by PR agency Dreyer & Kvetny



Projektmanagement Large Scale Projects Cross-Functional Management Track&Trace Regulatory Compliance Software Quality Assurance Agile Methodologies Digital Strategy PMO Support Veeva R&D SAP ATTP ICH SAP Serialization GxP CMC development Migration Integration Scrum Master Scrum Product Owner SAFe PRINCE2 ITIL IPMA

Produkte / Standards / Erfahrungen / Methoden


  • Result driven Senior Project Manager with experience in Veeva R&D, CMC, GxP, Serialization T&T, digitalization IT and transition project in the Pharma, Life Science and Finance Industry.
  • She has 25+ years of experience working as an IT professional, where she for the last 14 years professional has worked as Program and Project Manager.
  • She has successfully with sourcing partners managed, developed, implemented, and maintained several different projects within Life Science and Finance business.
  • She is a result driven Project Manager with focus on stakeholder management and desires to optimize processes and governance while focusing on the business and client value of the implementation.
  • She is characterized to lead and manage teams by coaching and encourage to develop and act. She works structured and keep a holistic overview to achieve the result.
  • She is logical thinking and have good analytical skills. She is empathic and naturally she builds up strong relations. She is a leader and a team player and is an easy-going Project Manager with a lot of energy and laughter.


  • Project Lead implementing Veeva R&D. RIM, eTMF, CTMS, QMS, Quality Docs, Vault Training, Station Manager
  • Implementing Stage Gate model and Portfolio Management in a GMP environment
  • Managing CMC in a GMP environment
  • Managing Serialization Track & Trace Project for entering the UAE and Bahrain market
  • Business and IT Development Project Management
  • Agile Management in a SAFe Framework
  • Robotic process automation and AI
  • Coach/Mentor to the Graduates Projects Trainee program
  • Operational Risk Management and Compliance
  • Strategy and innovation development
  • IT Enterprise Sales Management
  • IT Partner-, Development- and Alliance Management
  • IT Marketing and concepts

Specialist Skills

  • Veeva Quality R&D
  • CSV and GxP Validation
  • Data Migration
  • Integration
  • Serialization
  • TraceLink
  • SAP ATTP and ICH
  • CMC development
  • PMO and Governance
  • SAP Application development
  • Blue Prism AI
  • Test Automation


  • 4 years Veeva Quality R&D implementation as Program Manager
  • 12 years Business and IT Development Project Manager
  • 3 years PMO Management and CMC Stage Gate model implementation
  • 4 years Mentor for Graduating Program
  • 3 years managing CMC in a GMP environment
  • 2 years managing Serialization Track & Trace Project
  • 6 years IT Strategy and innovation development
  • 9 years IT Enterprise Sales and Partner Management

broad knowledge within GxP Project Management and Validation

  • Veeva Quality R&D implementations and strategy roadmap
  • Data Migration
  • Integration development
  • IT Process and transformation implementation
  • Masterdata management and clean-up
  • SAP Application development and maintenance
  • Tracelink Serialization, SAP ATTP and ICH implementations with 3PL partners
  • RPA Robotics Process Automation (BluePrism) implementation and tender management
  • GxP Computer System Validation


2022 - today

Role: Global Program Manager

Customer: NNIT

2018 - 2022

Role: Senior Project Lead Veeva R&D and CMC

Customer: Bavarian Nordic

2009 - 2018

Role: Project Manager, Agile SAFe Product Owner/Scrum Master

Customer:  ATP

2004 - 2007 

Role: Sales and Business Partner Manager

Customer: Magirus Nordic

1999 - 2004 

Role: Alliance/Partner-, Business Manager

Customer: HP / Compaq

1989 - 1999 

Role: Enterprise Sales Manager

Customer: WM-data / BFC Data

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