Job Title: Clinical Data Acquisition Expert
Business: Janssen UK
Who is Janssen? We're more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer's disease to cancer, we are committed to issues that touch everyone's lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That's why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.
The entry level position is primarily accountable for providing expertise in technical clinical data management activities, including, but not limited to, CRF technical development, data model specifications and mapping, data stream integrations, programs, reports and visualizations for data review, 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 systems, and create new standard). The incumbent will ensure high level of consistency and quality within and across trials.
This position ensures the 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 receives ongoing direction to achieve objectives. Work is reviewed on a regular basis.
1. 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.
2. 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.
3. 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.
4. 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.
5. Oversee development of data transfer agreements with ancillary data vendors ensuring use of standards, fit-for-purpose data models and transfer intervals.
6. Develop and maintain working knowledge of programming languages utilized in data management (SAS, SQL, etc).
7. Responsible for creation of submission-ready SDTM packages for FDA/PMDA or other regulatory authority submissions and keeping abreast in changing regulatory requirements.
8. Responsible for acquiring and maintaining working knowledge in the various and future evolving data collection tools applied in the clinical trial space such as Medidata Rave, LSAF, Pinnacle 21, and in CDISC standards such as SDTM, CDASH, Controlled terminology and define.xml.
9. Ensure standards are used at the trial level