Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Global Data Manager Specialist with a specific background in Oncology.At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit for more information.The Global Data Manager Specialist will be responsible to take a leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s). With the trial customer, CRO and other functional partners the Data Management Specialist establishes conventions and quality expectations for clinical data and sets timelines and follow-up regularly to ensure delivery of all Data Management milestones.This position makes recommendations and decisions that have an impact on specific trials or assignments. The GDM Specialist makes decisions for processes, timing, and structure for trials and assignments. This position makes recommendations for processes, timing, structure, and resources at a program level. This position analyzes, provides recommendations, and makes decisions with minimal direction from manager or DML.The successful candidate will have expert knowledge of the protocol and current clinical drug development processes is required. This position needs knowledge of applicable international guidelines regarding clinical trials end to end. Relevant system / technical knowledge is needed. This position requires expert knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) and the therapeutic area. In-depth knowledge of project management and techniques and knowledge of team management principles is required.He/She will take a leadership role with the CRO, the trial customer(s), GDM and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s). Identifies and communicates ways to improve deliverables.Takes a leadership role to gather content and integration requirements for eCRF and other data collection tools.Leads conventions and quality expectations for clinical data.Leads expectations for dataset content and structure.Sets timeline and follow-up regularly to ensure delivery of all data management milestonesEnsures trial level oversight controls are performed as described in the oversight plan, QC process, and work instructions.Ensures that clinical data management documents are reviewed accurately (including submission package) to facilitate appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.Oversees the assessment of real-time inspection readiness of all IDS deliverables for the trial. Participates in regulatory agency and J&J internal audits as necessary.Leads the planning and tracking of content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.Takes a leadership role with the assigned clinical working group(s) to ensure that IDS and TA trial needs and deliverables are met. Collaborates with the DML to develop scope of work and identify needed resources. Works with Infrastructure Organization to ensure all deliverables are effectively completed.Takes a leadership role to obtain and share best practices with internal partners. Leads others in implementing process, system, and tool improvement initiatives within IDS.Presents information and trains investigator and site monitors.QualificationsMaster s degree or professional experience equivalentMinimum Of Three Years Of Clinical Data Management Experience.Experience in clinical drug development within the pharmaceutical industry or related industry.Team Leadership Experience Is Required.Vendor oversight experience is required.Project Management Experience Is Required.2 year s experience in Oncology is required.Primary LocationUnited States-New Jersey-Raritan-OrganizationJanssen Research & Development, LLC. (6084)Job FunctionClinical Data ManagementRequisition ID067####### Associated topics: data analyst, data architect, data management, data quality, data warehousing, database, database administrator, hbase, mongo database administrator, teradata
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.