Marieke van der Berg

Prinsengracht 247
Amsterdam, Netherlands
+31 6 4829 5741
marieke.vandenberg@email.com
linkedin.com/in/marieke-vandenberg


PROFESSIONAL EXPERIENCE

Senior Clinical Data Manager (PBS)
Synergis Clinical Research, Amsterdam
March 2021 – Present

Lead clinical data management activities for multiple Phase II-IV oncology and hematology trials across global sites, ensuring compliance with Good Clinical Practice, ICH guidelines, and regulatory requirements. Oversee CRF design, database design and validation, medical coding (MedDRA, WHODrug), and data quality control processes for complex protocols involving 200+ patients per study. Collaborate closely with biostatistics, clinical operations, and regulatory teams to ensure timely database lock and data delivery for regulatory submissions. Manage cross-functional teams of 4-6 data management professionals and provide training on Oracle Clinical and data validation procedures. Implemented enhanced quality control procedures that reduced data query rates by 28% and accelerated database lock timelines by an average of 15 days.

Clinical Data Manager
Vertex Pharmaceuticals Europe, Utrecht
June 2017 – February 2021

Managed end-to-end clinical data management for Phase I-III trials in oncology and immunology therapeutic areas. Designed and validated clinical databases using Oracle Clinical, developed data validation specifications, and coordinated with Clinical Research Associates to resolve data discrepancies. Created and maintained data management plans, CRF completion guidelines, and data handling documentation. Performed medical coding using MedDRA and WHODrug dictionaries and ensured coding consistency across multiple studies. Conducted User Acceptance Testing and supported regulatory inspections and audits with zero critical findings. Trained junior data management staff and external vendors on study-specific procedures and quality standards.

Associate Clinical Data Manager
Novartis Clinical Services, Rotterdam
August 2014 – May 2017

Supported clinical data management activities for multiple Phase II-III trials in pharmaceutical development. Performed data validation, query generation and resolution, and quality control checks to ensure data integrity and compliance with protocol specifications. Assisted in CRF design, database setup, and preparation of data validation specifications. Generated data listings for Data Safety Monitoring Board meetings and interim analyses. Collaborated with biostatistics team to support statistical analysis and regulatory reporting requirements. Participated in quality assurance audits and implemented corrective actions to address findings.

Clinical Data Coordinator
Roche Diagnostics Netherlands, Almere
January 2012 – July 2014

Coordinated clinical data collection and processing activities for early-phase clinical trials. Performed data entry, quality control checks, and database maintenance in Oracle Clinical. Assisted with medical coding activities and maintained coding dictionaries. Supported preparation of study documentation including data management plans and standard operating procedures. Tracked and resolved data queries with clinical sites and monitored data completion metrics. Participated in database User Acceptance Testing and validation activities.


EDUCATION

Master of Science in Biostatistics
University of Amsterdam, Amsterdam
Graduated: May 2011

Bachelor of Science in Biology
Utrecht University, Utrecht
Graduated: May 2009


SKILLS

Clinical Data Management: Oracle Clinical, CRF Design, Database Design, Data Validation, Medical Coding (MedDRA, WHODrug), Quality Control, Data Processing

Regulatory & Compliance: Good Clinical Practice (GCP), ICH Guidelines, Quality Assurance, Protocol Compliance, Regulatory Documentation

Technical: SAS, SQL, R, Microsoft Excel, Unix, Windows

Therapeutic Areas: Oncology, Hematology, Immunology

Languages: English (Native), Dutch (Native), French (Professional), German (Conversational)

Other: Clinical Trials Management, Leadership, Training, Documentation, Statistical Analysis Support


CERTIFICATIONS

Certified Clinical Data Manager (CCDM), Society for Clinical Data Management
Issued: 2016

Good Clinical Practice (GCP) Certification
Renewed: 2024