Louise Pelgrim

Association of Clinical Research Professionals - Certified Professional

Louise Pelgrim
Renkum, Netherlands

Experience

Nov 2021 - Present
4 years 3 months

Freelancer | Study Manager | CRA

Pelgrim Clinical B.V.

  • Monitoring & site management
  • Essential document development & review
  • EC/CA submissions
  • ICH-GCP/ISO14155 compliance and training
  • Clinical audit
  • PMCF strategy & surveys
  • CTMS, eTMF, LMS, EDC
  • MDR/CTR/FDA
Jan 2017 - Nov 2021
4 years 11 months

CRO Lead | Sr. Clinical Consultant

Qserve Clinical Services B.V.

  • Monitoring & site management
  • Project, vendor and sponsor management
  • Clinical operations
  • ISO14155 (GCP) compliance and training
  • SOP/QMS development and maintenance
  • CTMS, eTMF, LMS, EDC
  • MDR/FDA
Oct 2016 - Oct 2020
4 years 1 month
Renkum, Netherlands

Sr. Clinical Consultant

Qserve Consultancy B.V.

  • Medical Device Regulation (MDR) transitions
  • Clinical Evaluation Reports (CER)
  • PMCF strategy, plans and training
  • ISO14155 (GCP) compliance and training
Oct 2015 - Sep 2016
1 year
On-site

Clinical Research Associate (CRA)

PPD Inc.

  • Monitoring & site management
  • ICH-GCP compliance
  • SOP/QMS compliance
  • Site management and on-site monitoring NL
  • CTMS, eTMF, LMS, EDC
  • CTR
Feb 2014 - Sep 2015
1 year 8 months
On-site

Analytical Clinical Research Associate (CRA)

Synthon B.V.

  • International on-site monitoring (US, NL, CZ, CAD, IND)
  • Vendor selection and management
  • Essential document development
  • ICH-GCP compliance
  • SOP/QMS maintenance

Skills

  • Pro-active
  • Result Oriented
  • Analytical
  • Accurate
  • Communicator

Languages

Dutch
Native
English
Advanced

Certifications & licenses

Association Of Clinical Research Professionals - Certified Professional

Association Of Clinical Research Professionals

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