Johnson & Johnson Careers
Senior Specialist Risk Management and Central Monitoring
Requisition ID: 1905751750W
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 seek 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’re 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.
You will execute and manage 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.
Major Duties & Responsibilities
- 35% Identifies and leads 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.
- 30% You will lead the cross-functional (CF)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. You will also provide ARBM-related input into the Monitoring Guidelines.
- 15% You will lead the CF Central Monitoring Working Group (CMWG) for Analytical Risk Based Monitoring studies.
- 15% You will be Contributing to the ongoing development of the ARBM model of clinical trial management and
- 5% Providing your input into lessons learned activities related to ARBM.
Do you hold the following Education, skills and knowledge we are looking for?
- You hold a Degree qualification at least to BSc preferably in Life Sciences, Pharmaceutical Sciences
- You have Pharmaceutical/Medical Device Trials experience within Clinical trials
- You are Knowledgeable of ICH-GCP and overall drug development processes.
- You able to operate and actively 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 clinical trials/clinical data.
- You have a Strong ability to effectively communicate and understand critical issues.
- You are skilled to an advanced level in allowing smooth and effective communication, including the ability to manage multiple communication streams.
- Ability to work with a set of pre-defined risks and adapt to new protocol-specific risks.
- Ability to successfully lead cross-functional study teams.
- Deep understanding of the Janssen R&D clinical operations model including the roles and responsibilities of the different partners preferred.
- Deep understanding of clinical research operations including on-site monitoring and site management is helpful.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)
Clinical Research non-MD