Gerly Van Der Vleuten Email & Phone Number

Oss, North Brabant, Netherlands

As the Global lead of the PKPD programming team within Certara, I have the following responsibilities:To develop and implement strategic plans to grow the PKPD programming organization and expand its service offerings. Provide leadership and direction to the PKPD programming team, ensuring the delivery of high-quality services to clients. Ensure compliance with industry standards, regulatory requirements, and company policies and procedures. Collaborate with cross-functional teams. Provide technical guidance and mentorship to team members, promoting a culture of continuous learning and development. Monitor and manage departmental budgets, resource allocation, and staffing needs. Monitor the PKPD programming team to prioritize and manage multiple projects in a fast-paced deadline driven environment while delivering high quality results. Conducts quality control and quality assurance activities on datasets and reports. Initialize and participate in company initiatives to improve quality and efficiency of the PKPD programming process.

Oss, North Brabant, Netherlands

As the Global lead of the PKPD programming team within Certara, I have the following responsibilities:To develop and implement strategic plans to grow the PKPD programming organization and expand its service offerings. Provide leadership and direction to the PKPD programming team, ensuring the delivery of high-quality services to clients. Ensure compliance with industry standards, regulatory requirements, and company policies and procedures. Collaborate with cross-functional teams. Provide technical guidance and mentorship to team members, promoting a culture of continuous learning and development. Monitor and manage departmental budgets, resource allocation, and staffing needs. Monitor the PKPD programming team to prioritize and manage multiple projects in a fast-paced deadline driven environment while delivering high quality results. Conducts quality control and quality assurance activities on datasets and reports. Initialize and participate in company initiatives to improve quality and efficiency of the PKPD programming process.

Oss, Noord-Brabant, Nederland

As the lead of the consulting team PKPD programming EU/APAC within Certara, I am responsible for managing the PKPD programmers, coordinating resource allocation and communication with other leads in North America. For new hires and junior programmers, I am the mentor during their first year at Certara.

Oss, North Brabant, Netherlands

As an Associate Director / Data Management Consultant I am responsible for the programming and validation in SAS or R of NONMEM-ready datasets to be used for PK/PD, efficacy and safety modeling, Also the creation of SAS transport files including define files for submission to authorities is part of the work as a PKPD programmer. For the submission to authorities, I am also involved in the creation of CDISC SDTM (PP) and ADaM (ADPC and ADPP) standard datasets and the define.html file using Pinnacle 21. Using Phoenix WinNonlin, I have been involved in the QC of PK and ADA analyses and reports.Within Certara Strategic Consulting, I am responsible for writing the Data handling SOP, Good programming Practices, development of Data Programming Specifications for NONMEM datasets and the QC checklist. As the lead in the PMx optimalization horizontal for Data programming I was part of a great team and we have standardized the data programming process from SoW until the submission package within Certara. Working instructions for the complete process have been written by me. And as part of the standardization, a standard program for population PK dataset creation has been developed and a QC application was created.

Oss, Noord-Brabant, Nederland

As the European lead of the PKPD programming group within Certara, I am responsible for coordinating resource allocation within EU and communication with other leads in North America. For new hires and junior programmers, I am the mentor during their first year at Certara. I am also involved in setting up internal training programs for cross-training between the PKPD programming group and the Biostatistical group. In 2022, I am the main faculty leader for module 3 on data handling during the Certara Africa Applied PMx Training program.

Oss, North Brabant, Netherlands

As a PK Scientist / Data Management Consultant I am responsible for programming and validation in SAS or R of NONMEM-ready datasets to be used for PK and PD modeling, and the creation of SAS transport files including define files for submission to authorities. I also create CDISC SDTM (PP) and ADaM (ADPC and ADPP) standard datasets and the define.html file.In addition, I perform QC on PK and ADA analyses and reports using Phoenix WinNonlin.As a Trial specialist I am involved in the set-up and review of (pre-)clinical outcome database that will be used for model-based meta-analysis (MBMA).Within Certara Strategic Consulting, I am responsible for writing the Data handling SOP, Good programming Practices, development of Data Programming Specifications for NONMEM datasets and the QC checklist. As the lead in the PMx optimalization horizontal for Data programming we have standardizing the data programming process from SoW until the submission package within Certara.

Oss, The Netherlands

As a Associate PK Scientist / Data Management Consultant I am responsible for the programming and validation in SAS or R of NONMEM-ready datasets to be used for PK and PD modeling, and the creation of SAS transport files including define files for submission to authorities. In addition, I perform QC of PK and ADA analyses and reports using Phoenix WinNonlin. As a Trial specialist I am involved in the setup and review of several (pre-)clinical outcome database that will be used for model-based meta-analysis. Within Certara Strategic Consulting, I was involved in writing the Data handling SOP, the Good programming Practices, the development of a PRS template for NONMEM datasets and a QC checklist.

Oss, The Netherlands

As a Associate PK Scientist / Data Management Consultant I was responsible for the validation and creation of NONMEM ready datasets, within SAS statistical software, to be used for pharmacokinetic and pharmacodynamic modeling. Also SAS transport files to be used for submission were created by me. As a consultant I had the lead in setting-up a pharmacokinetic and anti-drug antibody reconciliation process, with the involvement of multiple departments.Internally, I was involved in the standardization of the process to create and validate NONMEM-ready datasets, including standardization of variable names based on CDISC.

Oss, The Netherlands

As Clinical PKPD Scientist I am responsible for the validation and merging of NONMEM data sets for pharmacokinetic and pharmacodynamic modeling and PK datasets for NCA analyses, using SAS.

Eindhoven Area, The Netherlands

As a data manager, I am responsible for the implementation and improvement of the data management process at the department of Digital Pathology. As part of the improvement of the process, I was involved in the selection of an electronic data capture (EDC) system and/or CRO providing data management using an EDC system.In addition, all data management activities including design of case report forms, write the data management plan, give guidance to the data entry staff, data verification, data validation, query handling, locking of the database, creating SAS datasets and exporting the data to the statistician, are my responsibility.During this period I worked with the following Clinical Datamanagement System (CDMS): Evolve 5.0.

Oss, The Netherlands

As Clinical PKPD Scientist I am responsible for the validation and merging of NONMEM data sets for pharmacokinetic and pharmacodynamic modeling and PK datasets for NCA analyses, using SAS. The programming is based on a Performance Requirements Summary (PRS). When a graphical presentation of the data is required, I create the graphs with R. I am also responsible for writing one of the procedural guidances.During this period I worked with the following Clinical Datamanagement System (CDMS): InForm.

Oss Area, The Netherlands

As a senior data manager, I am responsible for the design of case report forms, the building of databases, setup of coding in the database, programming of consistency checks, data verification, data validation, coding of (serious) adverse event with MedDRA, coding of medication with WHODRUG, query handling, SAE handling, writing of narratives, reportings SUSARs to the authorities and exporting the data to the statistician. After the analyses of the data, I perform quality control on the statistical programs, output and the statistical report.Furthermore, as a mentor I am responsible for the training of the Clinical Data Entry associates, Clinical Data Management Associates and Clinical Data Managers.In addition I give input for data management proposals.Since 2009, I give guidance to the clinical data entry department.Since 2010, I give guidance to the clinical data management assocoates.In 2010, I performed the validation of a data management system on a new VMware server.In 2011, I was involved in the process of SOP writing.During this period I worked with the following Clinical Datamanagement Systems (CDMS): EXPeRT and Clintrial 4.2.

Oss Area, The Netherlands

As a data manager, I am responsible for the design of case report forms, the building of databases, setup of coding in the database, programming of consistency checks, data verification, data validation, coding of (serious) adverse event with MedDRA, coding of medication with WHODRUG, query handling, SAE handling, writing of narratives, reportings SUSARs to the authorities and exporting the data to the statistician. Furthermore, after the analyses of the data, I perform quality control on the statistical programs, output and the statistical report.Since 2009, I give guidance to the data entry department.During this period I worked with the following Clinical Datamanagement Systems (CDMS): Clintrial 4.2 and EXPeRT.

Oss Area, The Netherlands

As a data manager, I am responsible for the design of case report forms, the building of databases, programming of consistency checks, data verification, data validation, coding of (serious) adverse event with MedDRA, coding of medication with WHODRUG, query handling, SAE handling, writing of narratives, reportings SUSARs to the authorities and exporting the data to the statistician. Furthermore, after the analyses of the data, I perform quality control on the statistical programs, output and the statistical report.During the 6-day CRA course, provided several times a year at IMRO TRAMARKO, I provided the new CRA's with more information on ‘CRF design’ and ‘Data management’. During this period I worked with the following Clinical Datamanagement System (CDMS): Clintrial 4.2

Nijmegen Area, Netherlands

Ph.D. student at the department of General Internal Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands, supervisors: Prof. dr. Anton Stalenhoef, Dr. Jacqueline de Graaf and Dr. Henk Blom. Title of thesis: Familial Combined Hyperlipidemia, a complex multifactorial disorder