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Principal Clinical Data Acquisition Expert (m/f) Beerse Belgium,
Johnson & Johnson (company)
Posted on : 20 August 2017
- Our company 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 take a lead role to 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.
- Work is received in broad terms. Work may be reviewed during major deliverable.
- This position is provided with independence for execution. Work is completed in collaboration with cross functional groups, vendors and other managers.
- This position may lead cross-functional process improvement initiatives or take on a system ownership role.
- 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.
- 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, 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.
- This position can be accountable for process and/or system ownership.
- This position recognizes opportunities and contributes to solutions to strengthen the vendor/CRO relationship.
- Leads others in developing and implementing process, system and tool improvement initiatives within Data Delivery.
- The position mentors and coaches and may delegate work.
- A Bachelor s degree is required; Advanced degrees are preferred
- A minimum of 7 Years of experience in data management (data review, database management, standards development, statistical or data management programming, CRF build, etc) is required.
- A minimum of 4 years of in-depth project management skills and knowledge of team management principles are required
- Expert knowledge of protocol and current clinical drug development processes is required.
- Knowledge of international guidelines regarding clinical trials end to end is required.
- Expert knowledge of eDC systems, e.g. Medidata platform of tools, Clinbase eCOS, etc. is required.
- Expert SAS programming skills or other analytical programming language is required.
- In-depth knowledge of reporting tools, e.g. Spotfire is required.
- Expert 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 required.
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