- Entry level
- No Education
- Salary to negotiate
- High Wycombe
Job Title: Manager, Central Monitoring
Business: Janssen UK
Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.
We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That’s why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.
The Manager, Central Monitoring will be 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.
Principal Duties and Responsibilities:
• Oversee a group of professionals consisting of the Central Monitoring Managers (CMMs) in a matrix structure.
• Share responsibility for the quality of the data on compound, study, country and site levels with the assigned CMMs and with all applicable functions.
• Represent the Risk Management-Central Monitoring Group on program team meetings.
• Handle assignments that are more complex and/or have a greater potential impact on business results.
• 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.
• Oversee, execute and/or manage 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.
• Serve 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.
• Perform training, development, evaluation of staff performance and assists in hiring.
• Proactively assist the development and implementation and continuous improvement of the ARBM activities and generating detailed central monitoring group processes.
• A minimum of a Bachelor’s degree or equivalent University degree is required. Master’s degree preferred
• Clinical trials experience (i.e. clinical operations, data management, statistics, or other relevant clinical development experience) in the Pharmaceutical 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 required.
• Deep understanding of the Janssen R&D clinical operations model, including the roles and responsibilities of the different stakeholders preferred.
• The 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.
• The 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
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.