Specialist Data Acquisition Expert – External Data - 2406160884W

　　Description

　　Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Specialist Data Acquisition Expert – External Data to join our Data Acquisition & Coding (DAC) team within Integrated Data Analysis and Reporting (IDAR) Data Management .

　　This position can be located in Beerse, Belgium; Leiden, Netherlands; Allschwil, Switzerland; remote flexibility may be considered.

　　At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

　　Diversity & Inclusion are crucial to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions!

　　Are you ready to join a growing team driving the implementation of data acquisition strategy and the future e-clinical trial landscape at Janssen R&D?!

　　As a key member of the DAC team, the Specialist Data Acquisition Expert – External Data , uses in-depth knowledge on the collection, ingestion, transformation, and storage of External Data to support a diverse clinical development portfolio.

　　You will be empowered to drive data acquisition activities for a portfolio of trials and data streams of low to high complexity and serve as a subject matter expert on External Data domains (e.g., non-CRF, Devices & Apps, Electronic Health Records (EHR), Direct Data Capture).

　　The successful candidate will work in an agile, fast paced, highly motivated, team centric and evolving data environment. You will apply creative problem-solving skills and knowledge to support R&D innovation, staying abreast of relevant industry trends and innovative technologies related to External Data collection.

　　In this role, you will:

　　Collaborate cross-functionally and with external data providers to understand the purpose of data collected, align data availability and consumption requirements, and drive optimal data acquisition solutions.

　　Analyze data and content from external data streams and propose efficient pathways to acquire and integrate relevant data.

　　Lead the development and setup of traditional and novel data streams and related documents of low to high complexity.

　　Participate in continuous improvement initiatives contributing to innovation and the maturation of an industry leading data acquisition capability.

　　Actively contribute to the shaping of the organization, improving re-usability, efficiency, and consistency of DAC tools and processes across studies and therapeutic areas.

　　Qualifications

　　Qualifications

　　Bachelor’s degree in Health Sciences, Clinical Data Management or other relevant scientific field or equivalent work experience is required.

　　Minimum of 5 years relevant experience within the Pharmaceutical, CRO or Biotech industry, or equivalent is required.

　　Experience working in a multi-functional environment and ability to adapt to different ways of working is required.

　　Proven track record of effective communication skills, including strong verbal and written communication, influencing, and partnering skills is required.

　　Demonstrated experience working with external data providers, clinical data, and data structures within a clinical study/research setting is required.

　　Solid understanding of the overall drug development process and GCP/ICH guidelines is required.

　　Demonstrated understanding of relevant data collection, transfer, and submission industry standards (e.g., CDASH, SDTM, HL7 FHIR, ODM) is preferred.

　　Experience working with data from EHR/EMR, Digital Health technologies, and/or Real-World Data is preferred.

　　Deep expertise in specialized data streams (e.g., ‘omics data, immunogenicity, flow cytometry, PK, biomarkers) is preferred.

　　We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

　　We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

　　Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse

　　Other Locations Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Switzerland-Basel-Country-Allschwil

　　Organization Janssen Pharmaceutica N.V. (7555)

　　Travel Yes, 10 % of the Time

　　Job Function Clinical Data Management

　　Req ID: 2406160884W