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Manager, Risk Management and Central Monitoring
Requisition ID: 00001CHV
Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Manager, Risk Management and Central Monitoring. This position can be based remotely in North America.
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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Manager, Risk Management and Central Monitoring is accountable for the oversight, execution, and management of the Analytical Risk-Based Monitoring (ARBM) processes and day-to-day activities for one or more programs and/or assigned trials in conformance to all relevant laws, regulations, guidelines, policies and procedures. The Manager may have responsibility for overseeing a group of professionals consisting of the Central Monitoring Managers (CMMs) in a matrix structure. The Manager level CMM shares responsibility for the quality of the data on compound, study, country and site levels with the assigned CMMs and with all applicable functions.
The Manager will represent the Risk Management-Central Monitoring Group on program team meetings. The Manager is given assignments that are more complex and/or have a greater potential impact on business results. The Manager may lead initiatives related to continuous improvement of internal processes and also contribute to the mentoring/training of other CMMs in the Risk Management-Central Monitoring Group.
- Oversees, executes, and/or manages the RM-CM group activities across the various phases of
- ARBM trial design and execution as outlined in the end to end process, including tasks associated with start-up, execution and close out, and in all phases of trial monitoring for designated trials.
- Serves as the Risk Management-Central Monitoring representative for assigned programs/studies by establishing and maintaining liaisons with Program Teams, internal cross-functional colleagues, and/or with external contract research organizations.
- Performs training, development, evaluation of staff performance and assists in hiring
- Proactively assists the development and implementation and continuous improvement of the ARBM activities and generating detailed central monitoring group processes.
- Perform other work related duties as assigned.
- A minimum of a Bachelor’s degree (or University equivalent) is required. A Master’s degree is preferred.
- A minimum of 6 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 or Medical Device industry or Clinical Research Organization (CRO) is required
- Team Lead or functional management experience 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 pick up trends and early warning signals is required
- Ability to identify risk and trends 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
- Ability to manage multiple communication streams is required
- Ability to work with a set of predefined common risks, and ability to adapt/be flexible to adapt to protocol-specific risks is required
- Good understanding of clinical research operations, including on-site monitoring and site management is preferred.
- Ability to effectively lead cross-functional teams in a matrix environment required
- Experience training/mentoring less-experienced colleagues required
- Ability to identify and lead process improvement opportunities is required
- This position may be located remotely in the United States and may require up to 10% travel, both international and domestic
United States-Pennsylvania-Spring House
North America, Europe/Middle East/Africa
Janssen Research & Development, LLC. (6084)
Clinical Trial Administration