Kenix CJ Chang

Abschluss: Clinical Research Associate, Pharmaakademie
Berlin, Germany

Fähigkeiten und Kenntnisse

Budget Management
Preparation of tender
Administration
ISO 9001
SOP
Coordination
Taking Meeting Minutes
Technical writing
Internal Audit
people skills
presentation skills
Creative writing
MatLab
LabVIEW
OrCAD
ELISA
FACS Analysis
Western Blot
Microarray
MS-Word
Microsoft Excel
PowerPoint
MS Outlook
Phage Display
Cell Culture Technology
RNA Extract
ICH GCP
ISO 14971
ISO 13485
Molecular Biology
ISO 14155

Werdegang

Berufserfahrung von Kenix CJ Chang

  • Current 10 years and 11 months, since Aug 2015

    Volunteer

    Soli Deo Church, Halle, Germany

    Sorting clothes & other donation items, and participate in meetings for refugees

  • 1 year and 6 months, Oct 2012 - Mar 2014

    Laboratory Assistant

    Martin Luther University Hospital

    Culturing and studying the behaviour of 5 Hodgkin’s lymphoma (HL) cell lines, finding the relation between HL and human endogenous retroviruses (HERVs); DNA microarray, FACS Analysis, MACS magnetic isolation, RNA Isolation

  • 3 months, May 2012 - Jul 2012

    Laboratory Assistant

    Fraunhofer Institute of Cell Therapy and Immunology (IZI)

     Phage Display,  E. Coli bacteria culture

  • 1 year and 4 months, Jun 2010 - Sep 2011

    Assistant Manager

    Integrated Will Services Pte Ltd

    Managed daily correspondences with clients & administrative duties to ensure smooth running of the company

  • 6 months, Sep 2009 - Feb 2010

    Volunteer

    Yeovil Community Church (YCC) , UK

    Assisted in Parents & Toddlers group, played with the toddlers and built relationships with their parents,  Assisted in the operation of youth café & youth groups

  • 4 years and 7 months, Feb 2005 - Aug 2009

    Contracts and Negociations Officer

    Kajima (Malaysia) Pte Ltd

    Budget Control, Tender & Subcontracts Preparation, Interdepartmental Coordination (internal & external parties), Purchase Documents, Technical Documents

  • 11 months, Aug 2003 - Jun 2004

    Sales Support Engineer

    EP Engineering Pte Ltd

    Assisted project engineers in preparing tender documents; Ensured customer satisfaction by providing post-sales support

  • 11 months, Nov 2001 - Sep 2002

    Laser Engineer

    Optimax Laser Eye Centre Pte Ltd Malaysia

    Calibration, troubleshooting and preventive maintenance of laser machine used by doctors for daily Lasik eye surgery

Ausbildung von Kenix CJ Chang

  • 4 months, Jul 2016 - Oct 2016

    Clinical Research

    Pharmaakademie

    *ICH GCP*Monitoring Visits (PSV/SIV/RMV/COV)*Essential Docs(IB/ICF/CRF/TMF) *Pharmacovigilance(PSUR/DSUR/MedRA)*Authorities Submission(PEI, BfArM, EMA,BVL,BSF)*Law on Medical Devices & Drugs(AMG, MPG, ISO 14155,MEDDEV,GCP-V,CENELEC,CEN)*SOPs, Audits& Inspections,CAPA *Biostatistics*Medical subjects

  • Electrical engineering

    University of Technology, Malaysia

    Instrumentation & Control

  • Biomedical engineering

    Martin-Luther-Universität Halle-Wittenberg

Sprachen

  • German

    B1-B2 (Gute Kenntnisse)

  • English

    C2 (Verhandlungssicher / Muttersprachlich)

  • Chinese

    B1-B2 (Gute Kenntnisse)

  • French

    A1-A2 (Grundkenntnisse)

  • Malay

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