Analyst, Global Data Manager

Position: Analyst, Global Data Manager (1 of 3)
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 Med Tech, 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

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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Clinical Data Management

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at

Johnson & Johnson Innovative Medicine R&D is recruiting for an Analyst, Global Data Manager. This position is a hybrid role and can be located in Spring House, PA;
Horsham, PA;
Raritan, NJ; or Titusville, NJ.

The Analyst, 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 Analyst, 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).

This position receives ongoing direction to achieve objectives, and work is reviewed on a regular basis with the DML.

Principal Responsibilities:

* Work 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.

* Participate in establishing conventions and quality expectations for clinical data.

* Participate in establishing expectations for dataset content and structure.

* Work with others to 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. Work with DML to facilitate compliance with regulatory guidelines and the documentation matrix.

* Work with DML to facilitate real-time inspection readiness of all assigned deliverables for the trial. Participate in regulatory agency inspections and Johnson & Johnson internal audits as necessary.

* Work with DML to plan and track content, format, quality, and timing of applicable data management deliverables. Work with DML to ensure deliverables are on time.

* Support the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are met.

* Identify and communicate lessons learned with support from DML and frequently asked questions at trial level.

* Contribute to the creation of key functional plans (e.g., study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.

* Participate…