Analyst II, Clinical Data Manager

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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Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Clinical Data Management

Job Category:

Professional

All Job Posting Locations:

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 II, Clinical Data Manager. This position is a hybrid role and can be located in Raritan, NJ;
Titusville, NJ; or Spring House, PA.

The Analyst II, Clinical Data Manager is a professional individual contributor role at the junior level that will provide oversight and accountability and/or execute data management activities and/or perform scientific data review for more than one trial of low to moderate complexity or for one high complexity trial. This individual will make recommendations and influence decisions for specific trials or assignments.

Analyze and provide input into decisions with direction from manager or

Data Management Leader (DML). The work is received in broad terms and is reviewed on an ongoing

basis with the DML and the amount of instruction is limited.

Principal 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) 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.

* 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 (complex) scientific study data review and management of CDM, Study…