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Specialist Clinical Data Acquisition Expert (m/f)
Requisition ID: 1700185259W
Janssen Research & Development, L.L.C., a Johnson & Johnson Company, is hiring a Specialist, Clinical Data Acquisition Expert to be located in Leiden, The Netherlands.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The position is primarily accountable for providing expertise in technical clinical data management activities, including, but not limited to, case report form (CRF) technical development, data model specifications and mapping, data stream integrations, programs, reports and visualizations for data review, electronic CRF (eCRF) submission packages, and use of novel technologies and systems in the data management space. The incumbent will partner with Global Data Managers and Standards experts, where applicable, to evaluate and propose optimal technical solutions to meet protocol requirements and determine implementation plans (e.g., leverage CRO expertise, program internally, deploy new system, create new standard) as well as provide hands-on programming as appropriate in support of a trial. The incumbent will ensure high level of consistency and quality within and across trials.
This position acts as a deployment expert in the technical aspects of data management to ensure latest standards are being utilized, current technologies are deployed and system integrations are optimized. At the trial level, this position will drive use of standards for CRF builds and ensure best practices are used for edit checks, reports, and integrations. Additionally, this position will determine, in conjunction with the team, the data models required (SDTM, non-SDTM), will review data models for compliance with standards and will assist with the creation of new CRF, edit check, mapping and submission standards if needed.
This position is accountable for the delivery of technical data management components of the trials – data collection with integrations, reports and checks for data quality review and appropriately formatted datasets (SDTM or other) including the full esubmission ready data package. This position works together with the Global Data Manager to ensure the solutions are optimal to deliver the trial data content.
This position analyzes, provides recommendations and makes decisions with minimal direction from manager.
- Ensure eCRF is built according to the latest standards and best practices, including edit checks and applicable integrations (IWRS, CTMS, etc.); translate protocol requirements into optimal data capture approaches; oversee eCRF build and updates by CRO or vendor to confirm quality.
- Provide specifications for data models to be used for quality review and for final data model (SDTM or other); design mapping algorithms for non-standard conversions.
- Ensure quality review of datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive design, etc.) and compliant for Database lock.
- Program, or oversee programming of, quality review checks and reports for use by Global Data Managers and other team members.
- Ensure non-eCRF technologies for data capture (e.g., ePRO, safety reporting, coding, IWRS) are deployed as per requirements, including integrations with other systems, platforms or reporting environments with timelines for consumable data outlined.
- Oversee development of data transfer agreements with ancillary data vendors ensuring use of standards, fit-for-purpose data models and transfer intervals.
- Develop and maintain working knowledge and expertise in programming languages utilized in data management (SAS, SQL, etc.) and apply continuous learning as data management platforms evolve.
- Responsible for creation of submission-ready SDTM packages for FDA/PMDA or other regulatory authority submissions and keeping abreast in changing regulatory requirements.
- Responsible for acquiring and maintaining expertise in the various and future evolving data collection tools applied in the clinical trial space such as Medidata Rave, DTAs, Clinical Data Tools such as LSAF, Pinnacle 21, and in CDISC standards such as SDTM, CDASH, Controlled terminology and define.xml.
- Support the development of standards and drive their implementation within the organization.
- The position mentors and coaches and may delegate work.
- A Bachelor’s Degree or equivalent work experience is required.
- A minimum of 5 Years of experience in data management (data review, database management, standards development, statistical or data management programming, CRF build, etc.) is required.
- In-depth knowledge of protocol and current clinical drug development processes is required.
- A minimum of 2 years of in-depth project management skills and knowledge of team management principles are required.
- Knowledgeable of international guidelines regarding clinical trials end to end is required.
- In-depth knowledge of eDC systems, e.g. Medidata platform of tools, Clinbase eCOS, etc. is required.
- In-depth SAS programming skills or other analytical programming language is required.
- In-depth knowledge of reporting tools, e.g. Spotfire is required.
- In-depth knowledge of SDTM including Define.xml, CDASH, metadata is required.
- Ability to work with cross-functional team interpreting data requirements is required.
- Proven knowledge of good data management practices is required.
- Vendor management oversight experience is preferred.
- Project management skills required.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion, Janssen Research & Development, LLC is proud to be an equal opportunity employer.
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