Principal Data Acquisition Expert Edc
vor 1 Tag
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Principal Data Acquisition Expert - electronic Data Capture (eDC) to join our Data Acquisition & Coding (DAC) team within Integrated Data Analysis and Reporting (IDAR) Data Management to be based in Spring House, PA; Wayne/Chesterbrook, PA; Titusville, NJ; Raritan, NJ; High Wycombe, UK; Beerse, Belgium; Leiden, Netherlands; Allschwil, Switzerland. Remote work options in the United States or Europe may be considered on a case-by-case basis and if approved by the Company.
**Key Responsibilities**:
- Execute Data Acquisition responsibilities related to the setup and management of eDC systems for one or more trials of low to high 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.
- May serve as a business owner for processes/systems of low to medium complexity and/or significant departmental or cross-functional impact.
- 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**
Required:
- Bachelor’s degree in Health Sciences, Clinical Data Management or other relevant scientific field or equivalent work experience.
- Minimum of 7 years relevant experience within the Pharmaceutical, CRO or Biotech industry or equivalent.
- Demonstrated advanced experience working with industry leading eDC tools (e.g., Rave, Veeva, InForm) and related integrations (e.g., Safety Data, Coding, IWRS).
- Experience working in a multi-functional environment and ability to adapt to different ways of working.
- Proven track record of effective communication skills, including strong verbal and written communication, influencing, and partnering skills.
- Solid understanding of the overall drug development process and GCP/ICH guidelines.
Preferred:
- Demonstrated expert technical expertise in eDC systems (e.g., certified study builder, standards and library management, integrations support).
- Demonstrated advanced understanding of relevant data collection and submission industry standards (e.g., CDASH, SDTM).
- Ability to review protocol and translate into eDC requirements and specifications.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
**Primary Location**
United States-Pennsylvania-Spring House-Welsh & McKean Roads
**Other Locations**
North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States, Europe/Middle East/Africa-Switzerland-Allschwil, United States-New Jersey-Titusville, United States-Pennsylvania-Wayne, United Kingdom-England-High Wycombe
**Organization**
Janssen Research & Development, LLC (6084)
**Job Function**
R&D
**Requisition ID**
2206052445W
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