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Senior Specialist Central Monitoring Manager
High Wycombe, United Kingdom
Clinical Trial Administration
Requisition ID: 1805633018W
Job Title: Senior Specialist, Risk management and
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 Senior 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 Senior 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 Senior Specialist CMM may be given assignments that are more complex and/or have a greater potential impact on business results. The Senior Specialist may represent the Risk Management-Central Monitoring Group on program team meetings.
Duties and Responsibilities
The Senior Specialist will lead the cross-functional study team in the completion of ARBM-related study start-up processes, such as the protocol assessment, protocol de-risking, iARBM plan creation, establishment of initial site risk levels, and the creation of tSDV specifications. The Senior Specialist will also provide ARBM-related input into the Monitoring Guidelines.
Identifies and oversees potential issues and findings requiring further review and follow-up as part
of routine CMM work and CMWG conduct and ensures appropriate actions are taken by the central/local teams members (e.g. GCO, Portfolio Delivery, IDAR) to investigate, resolve and document potential risks identified via CMM data review, including ensuring adequate documentation of resolution.
Lead of the cross-functional Central Monitoring Working Group (CMWG) for Analytical Risk
Based Monitoring studies.
Providing input into lessons learned activities related to ARBM.
Contributes to the ongoing development of the ARBM model of clinical trial management and
Clinical trials experience (i.e. clinical operations, data management, biostatistics, or other relevant clinical development experience) in the pharmaceutical/medical device industry or CRO.
Knowledge of ICH-GCP and overall drug development processes.
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.
Data analysis and technical skills in the area of clinical trials/clinical data.
Strong ability to effectively communicate and understand issue escalation.
Advanced skills allowing smooth and effective communication, including the ability to manage multiple communication streams.
Ability to work with a set of predefined risks and adapt to new protocol-specific risks.
Ability to successfully lead cross-functional study teams.
What we’re about:
We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each
• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• Unique in our background and experiences
• The drivers of our own success
• Passionate about doing what’s right
Make a unique mark in your career
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com
We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
United Kingdom-England-High Wycombe
Janssen Cilag Ltd. (7360)
Clinical Trial Administration