Clinical Operations Consultant - Risk Based Quality Management

Are you a Clinical Project Manager, CRA, or expert Clinical Data Manager with a passion for using data to help manage risk in your studies? We've got a great Risk Based Quality Management Operations Consultant role to work for one of our clients. You will work with their Client Based which is Pharma, Biotech and CRO clients of all sizes and help them progress their risk management strategies. You will also be able to use your knowledge to develop software to support this.

Our client is growing at pace due to the success of their Industry leading products. We are looking for an Industry leading Operations Consultant who wants to apply knowledge and experience to the creation of a leading edge web application for the clinical trials industry.

They are leading global providers of Risk-Based Monitoring (RBM) solutions for clinical trials, and in order to expand its international presence and to keep up with the demand, they need to grow their team.

The RBQM Operations Consultant is a critical role, responsible for working with our customers to operationalise RBQM for clinical studies, including the implementation of our product into their operational practice. This role is a client-facing role and will work alongside the in house team to successfully implement our product into the client effectively, efficiently and to a high-quality standard.

You will be responsible for:

1. SoW ownership
2. Main liaison with client
3. Delivering to timescales
4. Responsible for project plan, budget and renegotiating statements of works
5. Creation and maintenance of project documentation as applicable to the role
6. Set up and lead kick off meeting
7. Support the performance of the protocol risk assessment, including facilitated risk assessments where contracted
8. Work with the client and in house teams to define risk controls including key risk indicators
9. Work with the client to further define key risk indicators e.g. what does it measure, what questions are you answering, what's the critical thinking around the route cause analysis
10. Support the client with the development of the overall monitoring strategy, including the centralized monitoring plan
11. Performing periodic centralized monitoring review of the Study and Site dashboards to provide insights in study and site risk profile and recommendations for action
12. Complete SOP Gap Analysis work where consulting has been sought from clients
13. Support the internal sales team as required for client RFPs and bid defense meetings
14. Act as internal stakeholder representing clients/end users as part of the software product development cycle.
15. Ongoing service support through the study

This is a great opportunity for someone who is interested in how we can make better use of data in clinical trials to determine which sites, patients and data are most at risk with a view to being able to identify the leading indicators that are predictive of study and site quality, and how to operationalize this in everyday clinical trial conduct.

1. Understanding of risk-based, centralized monitoring, ideally have worked with this methodology but not essential
2. Ability to review clinical protocols and understand the study design and subject visits schedules
3. Ability to apply an appropriate monitoring strategy to a study, based on the outcome of the risk assessment
4. Ability to demonstrate and apply critical thinking to KRI and data visualization design and centralized monitoring implementation
5. Desire to further develop centralized monitoring process and skills
6. Proven experience in managing client relationships/studies