Senior Clinical Data Manager

Company: Disability Solutions
Location: Raritan
Posted on: October 14, 2024

Job Description:

Johnson and Johnson is currently seeking an Senior Clinical Data Manager located in Titusville, NJ; Raritan, NJ; OR Spring House, PA. Remote work options in the United States may be considered on a case-by-case basis and if approved by the company.\rAt 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 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 humanity. Learn more at https://www.jnj.com/. \rFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.At Johnson & Johnson, we all belong.\rThe Senior Clinical Data Manager provides oversight and accountability and/or executes data management activities and/or performs scientific data review for multiple low, moderate and high complexity trials. The Senior Clinical Data Manager makes recommendations and decisions that have an impact on processes, timing, and structure for trials and assignments with minimal direction from manager or Data Management Leader (DML). This position also makes recommendations for processes, timing, structure, and resources at a program level. Work is received in broad terms, reviewed during major deliverables, and the amount of instruction is limited. Work is reviewed with the Data Management Leaders, or the immediate manager as needed.\r\r\rPrimary responsibilities:\r\r

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• Take 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:\ro Gather and/or review content and integration requirements for eCRF and other data collection toolso Establish conventions and quality expectations for clinical datao Establish expectations for dataset content and structureo Set timelines and follow-up regularly to monitor delivery of all data management milestones
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  • Ensure accurate review of related clinical data management documents as well as compliance with regulatory guidelines and documentation requirements.
  • Ensure real-time inspection readiness of all DM deliverables for the trial; participate in Regulatory Agency and J&J internal audits as necessary.
  • Lead the planning and tracking of content, format, quality, and timing of applicable data management deliverables. Ensure deliverables are on time.
  • Take a leadership role to obtain and share best practices with internal partners. Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.
  • Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
  • Identify and participate in process, system, and tool improvement initiatives.
  • Lead others in implementing process, system, and tool improvement initiatives.
  • Perform (complex) scientific study data review and management of CDM, Study Responsible Scientist (SRS, and Study Responsible Physician related queries in EDC system. Involvement in other clinical data review activities (e.g., Coding, SAE reconciliation) is possible.
  • Take a leadership role in collaborating with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved.\r\r\r

Keywords: Disability Solutions, Freeport , Senior Clinical Data Manager, Executive , Raritan, New York