Louise Pelgrim-Association of Clinical Research Professionals - Certified Professional
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Experience
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
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
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
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
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
Industry Experience
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Experienced in Healthcare and Pharmaceutical.
Business Area Experience
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Experienced in Quality Assurance, Research and Development, Operations, Project Management, and Procurement.
Skills
- Pro-Active
- Result Oriented
- Analytical
- Accurate
- Communicator
Languages
Certifications & licenses
Association Of Clinical Research Professionals - Certified Professional
Association Of Clinical Research Professionals
Statistics
Experience
Global Experience
Expertise
Qualifications
Profile
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Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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