Global Data Manager

3 weeks ago

Spring House, United States Disability Solutions Full time
Johnson & Johnson is currently seeking a Global Data Manager. This position can be located in Spring House, PA; Titusville, NJ; or Raritan, NJ.

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com.

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For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

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We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

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At Johnson & Johnson, we all belong.

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The Global Data Manager (GDM) is a professional individual contributor role at entry level that will provide oversight and accountability and/or execute data management activities and/or perform scientific data review for one or more trials of low to moderate complexity. The GDM will make recommendations and influence decisions for specific trials or assignments. This individual will analyze and provide input into decisions with direction from a manager or Data Management Leader (DML). Work is received in broad terms and reviewed on an ongoing basis with DML and the amount of instruction is limited.

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Principal Responsibilities:
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  • Take on a leadership role with external suppliers, trial customers and other internal/external partners to establish, align and confirm data management and/or clinical data management expectations to the business for assigned trial(s) to include but not limited to: - Gather and/or review content and integration requirements for Electronic Code of Federal Regulations (eCFR) and other data collection tools.
  • Establish conventions and quality expectations for clinical data.
  • Establish expectations for dataset content and structure.
  • Set timelines and follow-up regularly to monitor delivery of all data management milestones.
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  • Review clinical data management documents (including submission package) for appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensure compliance with regulatory guidelines and the documentation matrix.\
  • Ensure real-time inspection readiness of all DM deliverables for the trial and participate in regulatory agency and Johnson & Johnson internal audits as necessary.
  • Plan and track content, format, quality, and timing of applicable data management deliverables. Ensure deliverables are on time.
  • Take a leadership role with the assigned clinical working group(s) to ensure that DM and Therapeutic Area (TA) trial needs and deliverables are achieved.
  • Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
  • Identify and communicate lessons learned, best practices, and frequently asked questions at the trial level.
  • Identify and participate in process, system, and tool improvement initiatives.
  • Perform trial level oversight controls and/or execute data management activities per applicable procedures, with DML direction.
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