Global Data Manager

Johnson & Johnson • Raritan, NJ

340d

About The Position

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

Responsibilities

• 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).
• 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.
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees