Analyst I, Global Data Manager

Johnson & Johnson Johnson & Johnson · Pharma · Raritan, NJ +4

The Analyst I, Global Data Manager role at Johnson & Johnson focuses on clinical data management activities for trials. Responsibilities include establishing data management expectations, gathering requirements for data collection tools, collaborating on timelines, reviewing clinical data management documentation, supporting regulatory compliance, and participating in process improvement initiatives. The role requires a Bachelor's degree and preferred experience in clinical data management, drug development, and industry standards like CDISC.

What you'd actually do

  1. Working with external suppliers, trial customers, and internal and external partners to establish, align, and confirm clinical data management expectations for assigned trial(s).
  2. Gathering and/or reviewing content and integration requirements for eCRFs and other data collection tools, and participating in the establishment of conventions, quality standards, and expectations for clinical data, datasets, and data structures.
  3. Collaborating with cross‑functional partners to set timelines, plan, track, and monitor data management milestones and deliverables, ensuring agreed‑upon content, format, quality, and on‑time delivery with guidance from the Data Management Leader.
  4. Reviewing clinical data management documentation, including submission packages, to ensure appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency, and supporting compliance with regulatory guidelines and documentation requirements.
  5. Supporting real‑time inspection readiness for assigned trials, including participating in regulatory agency inspections and J&J internal audits as required, in collaboration with the Data Management Leader.

Skills

Required

  • Bachelor's degree or equivalent professional experience

Nice to have

  • Clinical data management experience
  • Knowledge of scientific concepts presented in clinical trial protocols
  • Experience in clinical drug development within the pharmaceutical or related industry
  • Knowledge of applicable international guidelines regarding data management of clinical trials
  • Knowledge of current industry standards (e.g., CDISC, SDTM, CDASH, etc.)
  • Knowledge of technology platforms for data exchange and project management