J&J Family of Companies Hiring for Principal Data Acquisition Expert – eDC at Greater Mumbai, India Full Time

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 – eDC to join our Data Acquisition & Coding (DAC) team within Integrated Data Analysis and Reporting (IDAR) Data Management.

Position locations: Greater Mumbai, India; remote flexibility may be considered.

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!

Position Summary

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 Principal Data Acquisition Expert – eDC, uses expert 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 high complexity, across a variety of compounds, disease areas, or therapeutic areas.

This position demonstrates strong technical skills and data scientific insights within the data acquisition capability, can think strategically and can effectively express ideas/concerns to senior management.

May take additional role responsibilities as a business owner for process and/or systems.

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

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

• 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.

• 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.

• Demonstrated advanced experience working with industry leading eDC tools (e.g., Rave, Veeva, InForm) and related integrations (e.g., Safety Data, Coding, IWRS).

• 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.

  Other:

  Travel: less than 10%

  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

India-Maharashtra-Greater Mumbai-

Organization

Johnson & Johnson Private Limited (8080)

Job Function

R&D

Requisition ID

2206051427W