Senior Specialist, Central Monitoring-00000LQX
Description
Janssen Research & Development, LLC, is recruiting for a Sr. Specialist, Central Monitoring to be based at any Janssen R&D site in the United States or Europe. However, this position can also be field based in the United States or in Europe. This job description has been posted for candidate proactive pipelining purposes and is not an actual open position. Candidates applying for this evergreen position will be placed in a database for consideration for future positions. Title and consideration is commensurate with experience.
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 Sr. 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 clinical research organizations to initiate and expedite clinical studies on products that have investigational new drug or medical device approvals. Ensures central monitoring of studies through interpretation of risk indicators and other trends, documents implications and provides status reports, follows up on completion of actions. Develops, and monitors the progress of clinical evaluation projects.
The focus of this position is to assist with the development and implementation of the Analytical Risk-Based Monitoring (ARBM) activities. 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 Trial Coordination and Site Management (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. The focus of this position is to proactively support the ARBM studies and the Manager, Central Monitoring with central monitoring of clinical trials. 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.
Qualifications
A minimum of a BS degree is required; Masters Degree or Equivalent is preferred.
A minimum of 3 or more years of relevant work experience is required.
A minimum of 3 or more years of Clinical trials experience required (i.e. clinical operations, data management, statistics, or other relevant clinical development experience) in the pharmaceutical in the pharmaceutical industry or CRO is required.
Team lead experience or functional management experience is required.
Knowledge of ICH-GCP and overall drug development processes is required.
Deep understanding of the Janssen R&D clinical operations model including the roles and responsibilities of the different stakeholders preferred.
Ability to operate and proactively use various systems and databases (CTMS, Rave, QRM Dashboard, Spotfire, etc.) to analyze trial quality/performance and compliance and pick up trends and early warning signals is required.
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 House
Other Locations:Europe/Middle East/Africa, North America-United States
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Clinical Trial Administration
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