Analyst I, Global Data Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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We are searching for the best talent for our Analyst I Global Data Manager position to be located in Raritan NJ; Titusville NJ; or Spring House PA.

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 Analyst Data Manager is a professional individual contributor role at entry level that provides oversight and accountability executes data management activities and may perform scientific data review for one or more trials of low to moderate complexity. The Analyst Data Manager makes recommendations and influences decisions for specific trials or assignments. This position analyzes and provides input into decisions with direction from manager or Data Management Leader. This position receives ongoing direction to achieve objectives and work is reviewed on a regular basis with the Data Management Leader.

You will be responsible for:

• Working with external suppliers trial customers and internal and external partners to establish align and confirm clinical data management expectations for assigned trial(s).
• 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.
• Collaborating with crossfunctional partners to set timelines plan track and monitor data management milestones and deliverables ensuring agreedupon content format quality and ontime delivery with guidance from the Data Management Leader.
• 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.
• Supporting realtime 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.
• Supporting assigned clinical working groups to ensure data management and therapeutic area trial needs and deliverables are met.
• Identifying documenting and communicating triallevel lessons learned and frequently asked questions with support from the Data Management Leader.
• Contributing to the development of key functional plans (e.g. Integrated Review Plans) ensuring appropriate quality scientific rigor organization accuracy and consistency.
• Performing triallevel oversight activities and executing data management activities in accordance with applicable procedures under the direction of the Data Management Leader.
• Participating in process system and tool improvement initiatives aligned with Global Data Management objectives.

Qualifications/Requirements:

• Bachelors degree (e.g. BS BA) or equivalent professional experience is required preferably in Clinical Data Management Health or Computer Sciences.
• Clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols is preferred.
• Experience in clinical drug development within the pharmaceutical or related industry is preferred.
• Knowledge of applicable international guidelines regarding data management of clinical trials is preferred.
• Knowledge of current industry standards (e.g. CDISC SDTM CDASH etc.) is preferred.
• Knowledge of technology platforms for data exchange and project management is preferred.
• Approx. <10% travel (domestic or international) may be required.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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Manager