Have you worked as a (clinical) data scientist? Are you familiar with SAS, LSAF, Excel or Pinnacle 21? Would you like to oversee the dataflow for multiple clinical trials at a large pharmaceutical company and act as a subject matter expert on all things data? Then this could be the role for you!
Job Description
At this site our client develops best-in-class pharmaceuticals and vaccines for some of the world's most life-threatening infectious diseases. The clinical data scientist implements and maintains efficient standard content in the data delivery tools (SAS, LSAF Excel based libraries) that can be applied across all the disease areas and therapeutic areas or to a specific therapeutic or disease area.
Responsibilities
- Implement the standard meta-data in the data delivery tools with the goal of creating efficiency within the trials, consistency across the trials and automating the data flow from source data to Data Review Models (DRM) sand to Study Data Tabulation Models (SDTM);
- Implement standard content in the delivery tools compliant to the industry standards and health authority regulations, meeting best practices in computer system validation, where applicable;
- Responsible for the correct testing and QC of the mapping metadata and therefore collaborates with the respective functions in Integrated Data Analysis (IDR) and Reporting;
- Annotate the eCRF or eCOA with Study Data Tabulation Models meta-data and collaborate with team members on the correctness of the annotated case report form meeting submission, scientific and operational requirements, and guidelines.;
- Define and maintain the clinical data delivery standards in line with the needs in clinical trials to meet additional scientific or operational requirements. To that end you will guarantee that formal change management control and versioning of the standards is applied and adhered to.
Requirements
- Master's or PhD degree in Data science, econometrics, computer science or similar;
- Experience with coding and running SAS programs is required;
- Knowledge of Rave eDC (Medidata Solutions) is a preferred;
- Expertise with CDISC standards: SDTM, Controlled terminology and define.xml;
- Experience with SAS LSAF and Pinnacle 21 is a plus;
- 3 years of relevant operational experience in clinical data management and standard relevant development experience in clinical data standards is strongly preferred;
- Experience in prioritizing and managing multiple tasks simultaneously;
- Outstanding written and verbal communication skills in English;
Benefits
- Employment: starting via Oxford Global Resources with prospect of a permanent position;
- Salary indication: €4200,- till €5700,- depending on educational level and experience;
- Working hours: full time, 40 hours;
- Vacation days: 25 days;
- Region: Leiden;
- Remote work is possible;
- Vacancy number: 17942.
As a specialized recruitment company, we at Oxford Global Resources have a large offer of IT jobs in the area of Computer System Validation (CSV) and Programmable Logic Controller (PLC) within various sectors, including Pharmaceuticals, Biotechnology, Contract Manufacturing, Contract Research, Food Industry, Chemicals, Environment and Plants.
Oxford is always looking for talent with expertise in Information engineering, IT, ICT, Biotechnology, Immunology, Biochemistry, Virology, Microbiology, Molecular Biology, Life Science, Analytical Chemistry, Physical Chemistry, Polymer Chemistry, Petrochemistry and Diagnostics. We would like to get in touch with candidates who have experience with one or more of the following technologies: PLC (Programmable Logic Controller), Computer System Validation (CSV), Citrix, Oracle, LIMS, Python, Vmware ESX, SQL, ITIL, SCRUM, Manufacturing execution system (MES), SCADA (Supervisory Control And Data Acquisition), Big data, Full stack development, Internet of things, Robotics, Data Science, Ethical Hacking, Security, Business Intelligence
Do you find this vacancy interesting? Or are you looking for a position at MBO, HBO, BSc, WO, MSc or PhD and are you interested in the job Research Technician, IT Architect, Enterprise Architect, IT Project consultant, Infrastructure Specialist, CSV Specialist, PLC Engineer, Automation Engineer, Control System Engineer, Process Engineer, Automation Specialist, PLC software engineer, IT Consultant. Then contact us directly!Oxford Global Resources is the largest recruitment agency within the fields of Science, Engineering and IT. All our recruiters have a relevant background within these fields and can help you find the perfect job through our extensive network.
As a specialist company we have a wide range of laboratory vacancies in Quality Control (QC) and Research & Development (R&D) within various sectors, including Pharmaceuticals, Biotechnology, Contract Manufacturing, Contract Research, Food Industry, Chemicals, Environment and Plants.
Oxford is always looking for talent with expertise in Biotechnology, Immunology, Biochemistry, Virology, Microbiology, Molecular Biology, Life Science, Analytical Chemistry, Physical Chemistry, Polymer Chemistry, Petrochemistry and Diagnostics. We are keen to meet candidates who have experience in one or more of the following techniques: USP (Upstream Processing) DSP (Downstream Processing), Bioprocesses, virus culture, cell culture, ELISA, FACS, Western Blot, SDS-page, PCR, RT-PCR, qPCR, cloning, sequencing, protein purification, purification, HPLC, UPLC, chromatography, physical chemistry, viscosity, melting point, pourpoint, pH, XRF, GC, GC-MS, LC, LC-MS, ICP ICP-MS, AAS, UV, titrations, Karl Fisher, formulation, sterility, determinations, bioburden, environmental monitoring, LIMS, GMP, GLP, GCP, GDP, ISO17025.
Do you find this vacancy interesting? Or are you looking for a position at MLA, HLO, BSc, WO, MSc or PhD and are you interested in the vacancy laboratory Assistant, Laboratory Assistant, Sample Preparation Laboratory Assistant, Analyst, Technician, Assistant Scientist, Associate Scientist, Scientist, Manufacturing Specialist, Process Engineer, Validation Engineer, QA (Quality Assurance) Officer, RA (Regulatory Affairs) Officer, Supervisor, Team Leader, Department Head, Laboratory Manager, Manager, Director, etc. Please contact us directly!
