Analyst II, Clinical Data Manager (1 of 2)
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 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 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: 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 https://www.jnj.com/innovative-medicine We are searching for the best talent for Analyst II Clinical Data Manager to be in Raritan, NJ, Springhouse, PA, Horsham, PA or Titusville, NJ, Purpose: The Analyst II Data Manager is a professional individual contributor role at junior level that provides oversight and accountability and/or executes data management activities and/or performs scientific data review for more than one trial of low to moderate complexity or for one high complexity trial. The Analyst II 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 (DML). Work is received in broad terms. Work is reviewed on an ongoing basis with Data Management Leader and the amount of instruction is limited You will be responsible for: ? 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: ? Gather and/or review content and integration requirements for eCRF and other data collection tools. o 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) ensuring 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 J&J 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 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. This position may be specialized into the following roles based on business needs: Global Data Manager (GDM), Clinical Data Manager (CDM) Global Data Manager role-specific responsibilities: ? Perform trial level oversight controls and/or execute data management activities per applicable procedures, with DML direction. Clinical Data Manager role-specific responsibilities: ? 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. ? Collaborate with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved. Principal Relationships: ? Reports into people manager position within functional area (e.g., Data Management Leader). ? Functional contacts within IDAR include but not limited to: Leaders and/or leads in Data Management and Central Monitoring, Clinical and Statistical Programming, Clinical Data Standards, Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system support organizations. ? Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but not limited to: Global Prog