Might be available
(Updated 2022-09-20)Technical Project Manager
Copenhagen, Denmark
Native Danish, English
- +5 years of Technical Assessment
- +5 years Techncial Project Management
- +5 years GxP and Pharma Compliance experience
Skills (28)
GxP
MAPPING
STRATEGY PLANNING
STEERING
CLINICAL TRIALS
DOCUMENTATION
RFP
Motion Tracking
Project Management
MVP
Kanban
FINANCIAL ANALYSIS
GMP
RISK ASSESSMENTS
Data Analysis
RISK ASSESSMENT
ORGANIZATIONAL CHANGE
GCP
PIPELINE
Pharmacovigilance
LAN
ACCOUNTING
GPS
OPERATIONAL SUPPORT
MARKETING ANALYSIS
TRANSLATIONS
MODEL-VIEW-PRESENTER
SHIPPING
Summary
Project Manager with strong validation and technical expertise in driving projects for
system implementation in regulated environments in the Pharma industry.
Bjarke holds experience from several pharmaceutical companies, employed and
consulting as project manager, product owner and technical business analyst across
the pharmaceutical life cycle. Primary focus and expertise from Clinical Research,
Regulatory Affairs and Product Supply.
Bjarke has a track record of introducing compliant technology advances in pharma
e.g.: DCT & ePRO system implementation; device testing, validation, and
implementation; and eSignature implementation. With this experience, Bjarke is well
accustomed to managing and completing the assignments for a technology track
through selection, assessment, validation, and implementation phases.
The consultant is used to working with cross-functional teams in highly complex
organizations and has strong stakeholder management and communicational skills.
He has legal and financial degrees which are used continuously in his various project
management roles and afford a deeper understanding of the broader implications of
specific solutions and actions.
Professional Experience
2020-04 - 2022-08
2022-09 - Present
Academic Background
2015-08 - 2017-06