Achraf A. Email & Phone Number

Rijswijk, Zuid-Holland, Nederland

As Lead Data Management and Reporting in Clinical Trial Services & Logistic Excellence, I oversee digital and reporting functions vital to global logistics, sample handling, and kit building. Key responsibilities include:Project Leadership and Digital Integration:* Lead digital and reporting projects, ensuring smooth integration of operational and transactional data.* Onboard new couriers and service providers, integrating them into the digital platform effectively.* Drive… Show more As Lead Data Management and Reporting in Clinical Trial Services & Logistic Excellence, I oversee digital and reporting functions vital to global logistics, sample handling, and kit building. Key responsibilities include:Project Leadership and Digital Integration:* Lead digital and reporting projects, ensuring smooth integration of operational and transactional data.* Onboard new couriers and service providers, integrating them into the digital platform effectively.* Drive digitalization efforts to enhance logistics, sample handling, and kit building processes.KPI Development and Reporting:* Develop and maintain a comprehensive logistics KPI matrix and portfolio.* Produce monthly management reports with actionable insights and recommendations.* Refine reporting standards and templates to meet changing business needs.Data Infrastructure and Management:* Design and improve data infrastructure for efficient analysis and reporting.* Ensure accuracy in presentations, manuscripts, graphs, and tables.* Develop and implement data management plans and standards, integrating new technologies as required.* Performing validation in line with GAMP5, GCLP, and GDP guidelines to ensure data integrity and compliance.Collaboration and Optimization:* Collaborate with senior management and cross-functional teams to enhance capabilities and progress.* Provide expert advice during client and stakeholder interactions.System Performance and Security:* Assess and recommend upgrades for hardware, software, and data storage.* Ensure data security through robust digital security systems.Skills:* Expertise in digital transformation, KPI development, and data management.* Strong abilities in designing data infrastructure and reporting.* Excellent collaboration, communication, and problem-solving skills.In this role, I drive operational excellence through strategic data management and reporting, supporting execution of clinical trials and logistics functions. Show less

Netherlands

As a Method Transfer Coordinator, I manage the transfer and optimization of methods for clinical trials and diagnostic processes, leading data management to ensure accuracy and compliance. My key responsibilities include:Method Transfer Coordination:* Oversaw the transfer and validation of analytical and diagnostic methods, ensuring they met regulatory standards and industry best practices.* Coordinated with cross-functional teams to integrate new methodologies into clinical… Show more As a Method Transfer Coordinator, I manage the transfer and optimization of methods for clinical trials and diagnostic processes, leading data management to ensure accuracy and compliance. My key responsibilities include:Method Transfer Coordination:* Oversaw the transfer and validation of analytical and diagnostic methods, ensuring they met regulatory standards and industry best practices.* Coordinated with cross-functional teams to integrate new methodologies into clinical trials and diagnostic workflows, developing and implementing transfer protocols.* Authored comprehensive documentation and training programs to support method adoption and maintain consistent performance.Clinical Trials and Diagnostic Methods:* Applied diagnostic techniques and clinical trial methodologies, enhancing data quality and process efficiency.* Led the validation of diagnostic assays and trial protocols, ensuring compliance with clinical and regulatory requirements.* Troubleshooting and resolving method performance issues, ensuring reliable results.Data Management Leadership:* Directed data management for clinical trials and diagnostic studies, handling data collection, entry, and analysis.* Utilized Python and Excel macros to automate data handling, streamline reporting, and improve efficiency.* Prepared and presented detailed data reports and documentation for internal teams, regulatory bodies, and study sponsors.Regulatory Compliance and Reporting:* Ensured compliance with regulatory requirements in all method transfer and data management activities.* Authored and reviewed regulatory submissions, including method validation reports and data management plans.* Provided training on regulatory standards and best practices, supporting teams in method transfer and data management.My role combines method transfer expertise with strong data management leadership, leveraging skills in Python and Excel macros to enhance clinical research and diagnostic accuracy. Show less

Rotterdam, Zuid-Holland, Nederland

In my role as a Senior Technician, I integrate advanced sequencing technologies with clinical research to drive innovation in viral genomics and therapeutic development. Key responsibilities include:Sanger Sequencing:*Performed high-accuracy Sanger sequencing for viral genome analysis, detecting mutations and genetic variants critical for patient outcomes.* Managed validation processes to ensure precise sequencing results, utilizing Python for automation of data processing and… Show more In my role as a Senior Technician, I integrate advanced sequencing technologies with clinical research to drive innovation in viral genomics and therapeutic development. Key responsibilities include:Sanger Sequencing:*Performed high-accuracy Sanger sequencing for viral genome analysis, detecting mutations and genetic variants critical for patient outcomes.* Managed validation processes to ensure precise sequencing results, utilizing Python for automation of data processing and analysis.*Documented procedures and results meticulously, generating comprehensive reports to support clinical trial documentation and regulatory submissions.Next-Generation Sequencing (NGS):* Applied NGS for comprehensive genomic profiling of viral pathogens and host responses in clinical trials.* Oversaw the entire NGS workflow, from sample preparation to data interpretation, using Python for advanced data analysis and visualization.* Validated NGS data through rigorous quality control and statistical analysis, ensuring accurate and reliable findings.* Developed and utilized Excel macros to automate data management, preliminary analysis, and reporting, improving efficiency and accuracy.Virology and Trial Management:* Coordinated and executed clinical trials targeting viral infections, ensuring compliance with protocols and regulatory standards.* Collaborated with multidisciplinary teams to integrate genomic data with clinical outcomes, supporting the development of targeted therapeutic strategies.* Prepared detailed trial reports and presentations for stakeholders, including internal teams, sponsors, and regulatory agencies.My expertise in sequencing technologies, combined with proficiency in Python and Excel macros, enhances data analysis and operational efficiency, contributing to the advancement of personalized medicine and innovative treatments for viral diseases. Show less

Rotterdam En Omgeving, Nederland

I’m responsible for two departments, performing assays at the Molecular biology department and the Bacteriology department.Tasks: * QPCR * PCR * SDS-PAGE * Gel Electrophoresis * ELISA * Disinfection test * Bioburden test TAMC TYMC * Specified Microorganism test * Titration * Control stocks * Extern environmental monitoring * Growth promotion of incoming goods * Writing SOP’s, validations, reports, deviations.* Looking into EP and… Show more I’m responsible for two departments, performing assays at the Molecular biology department and the Bacteriology department.Tasks: * QPCR * PCR * SDS-PAGE * Gel Electrophoresis * ELISA * Disinfection test * Bioburden test TAMC TYMC * Specified Microorganism test * Titration * Control stocks * Extern environmental monitoring * Growth promotion of incoming goods * Writing SOP’s, validations, reports, deviations.* Looking into EP and USP regulations to implement and improve assays Show less

The quality control department at de Plasma division is responsible for testing the quality of the final product. Tasks:• Liquid particle count• Bioburden assays• Endotoxin assays• Documentation, LIMS• Continues improvements• Sangermethode

Janssen, Pharmaceutical Companies Of Johnson And Johnson

The department of Primary Recovery is responsible for recovering monoclonal antibodies from harvest from the fermentation department. To recover this antibody we use a plastic gradient chromatography system in combination with a protein-A resin column. The resulting product containing pure monoclonal IgG antibodies is then concentrated further using ultrafiltration. This concentrate is then filtered one final time before storing.Tasks: • Using affinity chromatography with a PGCS… Show more The department of Primary Recovery is responsible for recovering monoclonal antibodies from harvest from the fermentation department. To recover this antibody we use a plastic gradient chromatography system in combination with a protein-A resin column. The resulting product containing pure monoclonal IgG antibodies is then concentrated further using ultrafiltration. This concentrate is then filtered one final time before storing.Tasks: • Using affinity chromatography with a PGCS system in combination with different resin column.• Ultra-Filtration• Pre and final filtration • Spectrophotometry• Microscopy• Documentation, SAP, LIMS• Continues improvements and Business improvements Show less

Janssen Biologics, Pharmaceutical Companies Of Johnson And Johnson

At the Down Stream Processing department product which is released from Primary Recovery, is guided through several (gel)filtration steps, (gel)column purifications combined with PGCS systems and virus removal steps before shipment to filling sites elsewhere.Techniques and equipment used: HPLC, Planova virus removal, Ion exchange chromatography, Molecular Exclusion Chromatography, Affinity Chromatography, PGCS, NFP.