Specialist, Central Monitoring (3 positions) Job

Job description

Specialist, Central Monitoring (3 positions)-00000XDIDescriptionJanssen Research & Development, LLC., a member of the J&J Family of Companies, is recruiting for a Specialist, Central Monitoring to be based at any Janssen R&D site in North America or Europe.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
The Specialist, Central Monitoring, plans, validates and manages the central monitoring process in conformance to all relevant laws, regulations, guidelines, policies and procedures. Responsible for planning and executing the central monitoring aspect of clinical trials being conducted under analytical risk based monitoring (ARBM).Duties & Responsibilities: Manages the day-to-day activities of the central monitoring of clinical trials in accordance with the standard operating procedures and good clinical practices. Creates and maintains liaisons with internal clinical trials administration and operations department and with external contract research organizations to ensure high quality of data in clinical studies through adequate management of risk signals and implementation of mitigation plans. Ensures central monitoring of studies through interpretation of risk indicators and other trends, documents implications and provides status reports and identifies actions, follows up on completion of actions. Shares responsibility for the quality of the data on study, country and site levels with the trial coordination and site management functions.
The role will execute the central clinical trial monitoring activities across the various phases of the trial execution as outlined in the end to end process. The range of tasks will include activities such as providing input into the integrated ARBM plan, monitoring guidelines and source data verification plan, ensuring historical site performance is gathered, performing trend analysis, maintaining oversight on site risk parameters and ensuring appropriate actions are taken by the TCSM organization to investigate the potential risks, monitor operational risk parameters at a trial level, spot checks of monitoring visit reports, lead lessons learned activities related to central monitoring. This position proactively supports the Manager, Central Monitoring with central monitoring of clinical trials and the scope of work will include tasks associated with pilot start-up, execution and close out, and in all phases of central monitoring for designated trials.
QualificationsA minimum of a BS degree is required; Master’s Degree or Equivalent is preferred. A minimum of 2 or more years of relevant work experience is required. Expertise in the areas of drug development, clinical trial operations, project management, process improvement initiative, or strategic planning is requiredKnowledge of ICH-GCP is required. Deep understanding of the Janssen R&D clinical operations model including the roles and responsibilities of the different stakeholders preferred.
Good understanding of clinical research operations including on-site monitoring and site management is preferred. Ability to operate and proactively use various systems and databases (CTMS, Rave, QRM Dashboard, Spotfire, Excel and Access etc.) to analyze trial quality/performance and compliance and pick up trends and early warning signals is preferred.
Ability to identify risk and trends required. Data analysis and technical skills in the area of clinical trials/clinical data is required.
Strong ability to effectively communicate and understand issue escalation is required.
Advanced communication skills allowing smooth and effective communication lines required. Ability to manage multiple communication streams is required.
Ability to work with a set of predefined common risk, and ability to adapt/be flexible to adapt to protocol-specific risks is required.
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Primary Location:North America-United States-Pennsylvania-Spring HouseOther Locations:North America, Europe/Middle East/AfricaOrganization: Janssen Research & Development, LLC. (6084)Job Function: Clinical Trial AdministrationCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement