Experience

Venn Life Sciences - part of hVIVO plc

• United Kingdom
• Research
• 1 - 100 Employee

• Clinical PK/PD Data Analyst

  • Apr 2016 - Present

  Responsible for the pharmacokinetic (PK)/Pharmacodynamic (PD) analysis in a clinical pharmacokinetic study (Phase 1 studies including first-in-man, ADME, drug-drug interaction, bioequivalence, or bioavailability; and PK studies during Phase 2/3). Non-compartmental PK/PD data analysis (NCA) is a procedure resulting in: - tables with amongst others concentration data and PK/PD parameters; - figures displaying the concentrations of the analyte or displaying PK/PD parameters; - the statistical analysis on concentration data or PK/PD parameters. The resulting data is reported in a PK/PD report. - Write PK Analysis Plans. - Data preparation (with use of Bioanalytical and CRF data). - Check on deviations and perform data handling. - PK/PD analyses. - Statistical analyses of PK/PD parameters. - Report data in tables and graphs which will be used for displays. - Prepare displays and addenda for the PK report. - Communicate results to the sponsor. - Review trial-specific NCA data transfer agreements, - Prepare and send out PK data transfers. - Prepare the study file for archiving. - Prepare the storage of electronic data. - Work according to ICH-GCP Guidelines and relevant SOPs and Manuals or according to Sponsor's requirements. Show less



Eurofins Central Laboratory

• United States
• Biotechnology Research
• 200 - 300 Employee

• Data Manager

  • Jun 2009 - Mar 2016

  Acting as a global project leader regarding lab data management activities for clinical trials. Setting targets and determining priorities, planning and keeping track of deadlines. Making sure that clinical laboratory data is delivered on time and with high quality to maximize client satisfaction. Working by ICH-GCP guidelines and Eurofins SOPs. - Lead data manager for multiple global clinical trials simultaneously. - Global coordination and management of central laboratory services (laboratory data) for clinical trials, from study set-up till database closure. - Primary contact for internal and external clients regarding clinical trial design in the database (LIMS: Laboratory Information Management System), electronic data transfers, and all other data management related activities. - Review of data management documents (laboratory protocols, data transfer specifications, SOPs), ensuring appropriate quality and compliance with regulatory guidelines and SOPs. - Perform appropriate QC according to global procedures and agreed upon specifications to ensure high-quality data to the client. - Perform set-up of LIMS and data portals, according to study specific laboratory protocols. - Create data transfer specifications (DTS), and convert and transfer electronic data to the clients according to DTS (ASCII, SAS). - Adjust existing SAS programs regarding data transfers. - Collaborate with project management, laboratory, and IT to ensure a smooth data flow to the client during execution of central laboratory testing in clinical trials. - Supervise data management assistants and train/coach colleagues new on the job. - Perform data reconciliation and supervise data cleanings, to ensure overall integrity and consistency. - Compile study files including all data management documentation and activities, and ensure that these are accurate, maintained, complete, and self-explanatory in such way that they will pass regulatory inspection. - Responsible for timely database lock. Show less



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• GLP QA auditor

  • Sep 2008 - May 2009

  Conducting internal audits, based on GLP guidelines.- Protocol review.- In-life inspections.- Report audits.

• Clinical Data Manager

  • Aug 2006 - Aug 2008

  Responsible for the quality of data in the clinical trials database by assuring that data are accurate, complete, clinically and medically relevant, and ready for statistical analysis reporting, based on ICH-GCP guidelines.Lead Clinical Data Manager tasks.- Review of Clinical Protocols.- Write Data Management Plans.- Write Trial Functional Specifications.- Define and validate data checks en listings.- Collaborate with Clinical Database Analysts.- Train investigators and site managers.- Assist in creating Case Report Forms (CRFs).- User Acceptance Testing.- Train Data Entry associates; write data entry instructions.- Set up the Database.- IVRW/IWRS integration.- Review of clinical data and central lab data (data verification and validation).- Write and solve queries.- Code Adverse Events (AEs) and Concomitant Medication (ConMeds).- Reconcile Serious AEs.- Give feedback to investigators and site managers.- Follow up on the Data Management status with the clinical team.- Take care of database locks. Show less



Organon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Data Analyst

  • May 2006 - Jul 2006

  Responsible for clinical data management activities related to research conducted by the Clinical Trial Operations division, based on ICH-GCP guidelines. - Review of clinical data. - Write and solve queries. Responsible for clinical data management activities related to research conducted by the Clinical Trial Operations division, based on ICH-GCP guidelines. - Review of clinical data. - Write and solve queries.



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Data Manager

  • Feb 2005 - Apr 2006

  Responsible for the quality of data in the clinical trials database by assuring that data are accurate, complete, clinically and medically relevant, and ready for statistical analysis reporting, based on ICH-GCP guidelines. Responsible for the quality of data in the clinical trials database by assuring that data are accurate, complete, clinically and medically relevant, and ready for statistical analysis reporting, based on ICH-GCP guidelines.



Zorginstituut Nederland

• Netherlands
• Government Administration
• 400 - 500 Employee

• Junior Project Coordinator

  • Jul 2002 - Dec 2004

  Responsible for the coordination and review of research projects as part of the research programmes “Developmental Medicine” and "Efficiency Academic Hospitals" (mainly clinical trials). Take care of reports with lines of policy to the minister of Health, Welfare and Sports. - Review of research reports. - Communication with internal and external clients. - Keep an eye on study timelines and budgets. - Write summaries of the research reports from the investigators. - Take care of reports with lines of policy to the minister of Health, Welfare and Sports. - Responsible for archiving of study documentation, with the help of an administrative assistant. Show less