Specialist, Risk management and Central Monitoring
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies is recruiting for a Specialist, Risk management and Central Monitoring to be based at any Janssen R&D site in North America, Europe, Beerse, Belgium and/or Leiden, Netherlands.
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 http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
- The Specialist executes and manages the Analytical Risk-Based Monitoring (ARBM) processes and day-to-day activities for up to five trials of medium complexity and three trials of high complexity or a combination of high and medium complexity trials in conformance to all relevant laws, regulations, guidelines, policies and procedures
- The focus of this position is to take primary responsibility for the ARBM-related study set-up processes and to manage the execution of central monitoring activities assigned to the CMM(s) during trial execution, as outlined in the end to end process, including maintaining oversight of site/regional/study risk parameters
- The Specialist leads the preparation, conduct, and follow-up of the cross-functional Central Monitoring Working Group (CMWG) for Analytical Risk Based Monitoring studies and shares the responsibility for the quality of the data with all applicable functions.
- The Specialist CMM may be given assignments that are more complex and/or have a greater potential impact on business results.
- The Specialist may represent the Risk Management-Central Monitoring Group on program team meetings.
- A minimum a Bachelor’s Degree with 3 or more years of relevant work experience is required
- Clinical trials experience (i.e. clinical operations, data management, biostatistics, or other relevant clinical development experience) in the pharmaceutical/medical device industry or CRO is required.
- Knowledge of ICH-GCP and overall drug development processes is required.
- Ability to operate and proactively use various systems and databases (CTMS, Rave, QRM Dashboard, Spotfire, etc.) to analyze trial quality/performance and compliance and identify trends and early warning signals is 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 skills allowing smooth and effective communication, including the ability to manage multiple communication streams is required.
- Ability to work with a set of predefined risks and adapt to new protocol-specific risks is required.
- Ability to successfully lead cross-functional study teams is preferred.
- Good understanding of clinical research operations including on-site monitoring and site management is preferred
- This position requires up to 10% domestic and international travel
Johnson & Johnson is an equal opportunity employer
United States-Pennsylvania-HorshamOther Locations
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-AntwerpOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Trial AdministrationRequisition ID