Stine Abildgaard Knudsen
Clinical Project Manager at InnoCon Medical- Claim this Profile
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English Professional working proficiency
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Danish Native or bilingual proficiency
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German Elementary proficiency
Topline Score
Bio
Credentials
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Clinical Evaluation for Medical Devices in Europe and International Approach
MedicoindustrienMay, 2020- Nov, 2024 -
Root Cause Investigation for CAPA
Weaver Consulting LLCSep, 2019- Nov, 2024 -
Internal Auditing for Medical Device Companies and ISO 19011
MedicoindustrienApr, 2019- Nov, 2024 -
Quality Management for Medical Devices and ISO 13485
MedicoindustrienApr, 2019- Nov, 2024 -
Introduction to GCP for Site Staff
GCP-enhederne i DanmarkMar, 2018- Nov, 2024 -
ICH GCP (R2)
ICON Central LaboratoriesMar, 2017- Nov, 2024 -
Medidata Rave® Certified Clinical Research Coordinator
Medidata SolutionsMar, 2017- Nov, 2024 -
Rave Advanced Rave EDC for Site Users
Medidata SolutionsMar, 2017- Nov, 2024 -
Rave EDC Essentials for Clinical Research Coordinators
Medidata SolutionsMar, 2017- Nov, 2024 -
Rave Query Management
Medidata SolutionsMar, 2017- Nov, 2024 -
Sygeplejevikarkursus
FADLMay, 2014- Nov, 2024
Experience
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InnoCon Medical
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Denmark
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Medical Device
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1 - 100 Employee
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Clinical Project Manager
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Mar 2019 - Present
• Designing clinical investigations (MDR, ISO 14155)• Writing documentation for competent authorities and ethical committees• Monitoring of investigational sites
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Quality Management Specialist
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Mar 2019 - Present
• Development and maintenance of QMS (MDR, ISO 13485 and FDA 21 CFR Part 820)• Internal and external auditor • Document QA• Risk management (ISO 14971)• NC and CAPA management• Service provider management
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Life Science Robotics
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Denmark
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Medical Equipment Manufacturing
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1 - 100 Employee
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Clinical Trial Associate
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Nov 2018 - Feb 2019
• Clinical Evaluation Report for a rehabilitation robot in accordance with MEDDEV 2.7/1 rev. 4. • GCP for medical devices (ISO 14155) • Marketing material • Product development – Concept generation and requirements specifications • Quality Assurance and Management • Risk Analysis and Risk-Benefit Analysis • Compliance with SOPs and ensuring proper documentation • Coordination of project work • Clinical Evaluation Report for a rehabilitation robot in accordance with MEDDEV 2.7/1 rev. 4. • GCP for medical devices (ISO 14155) • Marketing material • Product development – Concept generation and requirements specifications • Quality Assurance and Management • Risk Analysis and Risk-Benefit Analysis • Compliance with SOPs and ensuring proper documentation • Coordination of project work
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Quality Associate
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Jan 2018 - Jun 2018
I completed my master’s thesis in collaboration with the Hospital Pharmacy in the North Denmark Region. • Management of the emergency drug kits at the hospital pharmacies in Denmark • Ensuring compliance with GMP and GDP • Quality assurance and development • Evaluation of standardized working procedures • Pharmaceutical tender • Development of a economic tool for purchasing pharmaceuticals • Communication of findings and suggestions for optimization to stakeholders I completed my master’s thesis in collaboration with the Hospital Pharmacy in the North Denmark Region. • Management of the emergency drug kits at the hospital pharmacies in Denmark • Ensuring compliance with GMP and GDP • Quality assurance and development • Evaluation of standardized working procedures • Pharmaceutical tender • Development of a economic tool for purchasing pharmaceuticals • Communication of findings and suggestions for optimization to stakeholders
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Care Support Worker
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Nov 2015 - Jun 2018
I worked as a Care Support Worker at a residence for deafblind and cognitively impaired citizens. • Ethical decision making • Maintaining a calm approach and organize tasks during stressful situations • Tactile sign language • Helping the citizens through their daily lives I worked as a Care Support Worker at a residence for deafblind and cognitively impaired citizens. • Ethical decision making • Maintaining a calm approach and organize tasks during stressful situations • Tactile sign language • Helping the citizens through their daily lives
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Aalborg Universitetshospital
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Denmark
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Hospitals and Health Care
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700 & Above Employee
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Clinical Research Coordinator/Research Assistant
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Feb 2017 - Aug 2017
I worked in a randomized controlled phase IIa study investigating an anti-NGF antibody in patients with osteoarthritis. • Site initiation visit and investigator meetings • Prescreening and recruitment of patients • Planning of patient visits incl. x-rays, blood tests and EKG • Ensuring proper documentation in the eCRFs and trial master file • Communication with patients, healthcare professionals, the CRO and sponsor • Ensuring compliance with the regulatory requirements incl. ICH-GCP • Patient safety • Project management Show less
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FADL
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Denmark
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Civic and Social Organizations
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200 - 300 Employee
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Sygeplejevikar (Nursing Assistant)
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May 2014 - Oct 2015
I worked as an on-call nursing assistant at the hospitals in the North Denmark Region. • Communication with healthcare professionals • Patient care and communication • Ethical aspects of caring for all types of patients incl. those with special needs, psychiatric disorders, etc. I worked as an on-call nursing assistant at the hospitals in the North Denmark Region. • Communication with healthcare professionals • Patient care and communication • Ethical aspects of caring for all types of patients incl. those with special needs, psychiatric disorders, etc.
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Education
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2016 - 2018
Aalborg Universitet
Master of Science (MSc), Industrial Medicine with focus on Translational Medicine -
2013 - 2016
Aalborg Universitet
Bachelor of Science (BSc), Industrial Medicine -
2010 - 2013
Mariagerfjord Gymnasium
High School, Mathematics, chemistry and physics
Community
