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Maarten Knaepen

Maarten Knaepen

Consultant

IQVIA

Technologies

My Portfolio Highlights

My New Course

Introduction to Functions in Python

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DataCamp Course Completion

Take a look at all the courses I’ve completed on DataCamp.

My Work Experience

Where I've interned and worked during my career.

IQVIA | Mar 2022 - Present

Database Delivery and Oversight Lead

Pro-actively identify and provide oversight to the operational delivery and implementation of Clinical Metadata Repository system (CMDR) across clinical trials based on their characteristics. Based on UCB strategic CMDR implementation decisions and using UCB standard libraries existing in metadata repository lead and provide oversight to create study level deliverables such as: • Basic eCRF including forms, form instructions, controlled terminologies edit checks, e-mail alerts etc • Data transfer specification dataset structures for clinical data collected outside of eCRF (e.g. central laboratory, eCOA etc) • SDTM datasets and RAW to SDTM mappings Coordinate the collaboration with UCB colleagues and CRO Partners to align on timelines to finalize the design, creation and implementation of EDC solutions. In collaboration with Study Data Leads provide leadership to the planning for data receipt and data quality oversight throughout the duration of clinical trials assigned to the Database Delivery and Oversight team. Lead the execution or execute the process of data loads from various sources into the clinical and operational data repositories including the review and communication of issues. Sources may include: • Strategic Partners • Non-strategic vendors/CROs • Central Labs • Imaging Vendors • Other data sources relevant for the conduct of clinical trials
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Covance | Jan 2020 - Apr 2022

Electronic Data Specialist

Responsible for training 3 new colleagues in basic EDS (electronic data specialist) tasks, assigned workloads and respected deadlines. Reviewed data discrepancies generated by edit checks for external data and performed subsequent query management to resolve issues. Assisted with review of external data edit checks, validated electronically transmitted data. Entered and performed QC for local laboratory normal ranges. Communicate problems involving data transfers, data point issues and validation issues to vendors and clients.

IQVIA | Jan 2022 - Feb 2022

Database Delivery and Oversight Lead

Pro-actively identify and provide oversight to the operational delivery and implementation of Clinical Metadata Repository system (CMDR) across clinical trials based on their characteristics. Based on UCB strategic CMDR implementation decisions and using UCB standard libraries existing in metadata repository lead and provide oversight to create study level deliverables such as: • Basic eCRF including forms, form instructions, controlled terminologies edit checks, e-mail alerts etc • Data transfer specification dataset structures for clinical data collected outside of eCRF (e.g. central laboratory, eCOA etc) • SDTM datasets and RAW to SDTM mappings Coordinate the collaboration with UCB colleagues and CRO Partners to align on timelines to finalize the design, creation and implementation of EDC solutions. In collaboration with Study Data Leads provide leadership to the planning for data receipt and data quality oversight throughout the duration of clinical trials assigned to the Database Delivery and Oversight team. Lead the execution or execute the process of data loads from various sources into the clinical and operational data repositories including the review and communication of issues. Sources may include: • Strategic Partners • Non-strategic vendors/CROs • Central Labs • Imaging Vendors • Other data sources relevant for the conduct of clinical trials

Chiltern | Dec 2018 - Jan 2020

SDTM specialist

Experienced with SDTM and able to implement maintain and ensure strict compliance with CDISC or client-specific SDTM standards. Created and reviewed CDISC complient programming specifications. Created and reviewed SDTM compliant annotated CRF's.

My Education

Take a look at my formal education

Master's degree, Biomedische wetenschappen (Biomedical Sciences)KU Leuven | 2017
Bachelor's degree, Biomedical Laboratory TechnologyKatholieke Hogeschool Limburg | 2013

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