Senior Data Acquisition Expert - eDC.

Job content

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

This position is to be located in Springhouse, PA; Chesterbrook, PA; Titusville, NJ; Raritan, NJ; High Wycombe, UK; Beerse, Belgium; Leiden, Netherlands; Allschwil, Switzerland; remote flexibility may be considered in the countries listed.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to build a world without disease. Redefining 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.

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 Senior Data Acquisition Expert - eDC, uses in-depth knowledge to provide trial-level support for the setup and management of Electronic Data Capture (eDC) systems and their related components and activities.

You will be empowered to lead a portfolio of trials of low to moderate complexity, across a variety of compounds, disease areas, or therapeutic areas.

The successful candidate will work in an agile, fast paced, highly motivated, team centric and evolving data environment applying creative problem-solving skills and relevant knowledge to support R&D innovation.

In This Role, You Will

• Execute Data Acquisition responsibilities related to the setup and management of eDC systems for one or more trials of low to moderate complexity.
• Collaborate cross-functionally to understand the purpose of data collected and define trial level requirements related to eDC systems.
• Ensure correct adoption of clinical data standards to guarantee consistency across studies, compounds, disease areas, and therapeutic areas.
• Provide oversight on external partners performing data management activities on Janssen’s behalf or execute the data management activities internally.
• 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

• Bachelor’s degree in Health Sciences, Clinical Data Management, Nursing or other relevant scientific field, or equivalent work experience is required.
• Minimum of 3 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 industry leading eDC tools (e.g., Rave, Veeva, InForm) and related integrations (e.g., Safety Data, Coding, IWRS) is required.
• Good understanding of the overall drug development process and GCP/ICH guidelines is required.
• Demonstrated advanced technical expertise in eDC systems (e.g., certified study builder, standards and library management, integrations support) is preferred.
• Demonstrated understanding of relevant data collection and submission industry standards (e.g., CDASH, SDTM) is preferred.
• Ability to review protocol and translate into eDC requirements and specifications is preferred.
• #GIFTS
  
  

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

United States-Pennsylvania-Spring House-Welsh & McKean Roads

Other Locations

Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Chesterbrook, Europe/Middle East/Africa-Switzerland-Allschwil, Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-United Kingdom, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2206004673W