Are you a clinical project manager, CRA or another clinical trials expert who is passionate about risk based study management? We've got a great Risk Based Quality Management Operations Consultant role, ideally based in Cambridge, but working with clients to help them with excellence in risk based study management.

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.

Role Overview

The RBQM Operations Consultant is a critical role in our business model, responsible for working with our customers to operationalize 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 RBQM Implementation Consultant to successfully implement our product into the client effectively, efficiently and to a high-quality standard.

The role is responsible for overseeing the relationship with the client and delivery of the product, from protocol risk assessment and definition of the monitoring strategy, through to centralized monitoring activities within the product, including facilitating meetings such as the Kick-Off meeting for the project and the workshops for risk assessment and KRI identification, plus providing relevant demos and training to clients. This role may also be called upon to conduct facilitated risk assessments with clients, to perform SOP analysis for clients that have engagedour client for this consultancy work, and may support the internal sales team with client RFPs and bid defense meetings as required.

As an RBQM Operations Consultant, you will review client protocols to determine critical data and processes, identify and evaluate risks, and ascertain what controls can be applied to the identified risks. You may also be required to determine an appropriate monitoring strategy for the study based on the outcomes of the risk assessment.

Following on from this risk assessment and monitoring strategy review, you will work alongside the RBQM Implementation Consultant and the client team to identify relevant KRIs that can be applied to the study dependent on the risks that have been identified.

Once the study has been released into production, this role will be responsible for supporting the client study teams during the centralized monitoring cycle to review the KRIs, develop insights into site risks, the risk profile of the study, if risk thresholds need to be adjusted etc.

You will be responsible for:

• SoW ownership
• Main liaison with client
• Delivering to timescales
• Responsible for project plan, budget and renegotiating statements of works
• Creation and maintenance of project documentation as applicable to the role
• Set up and lead kick off meeting
• Support the performance of the protocol risk assessment, including facilitated risk assessments where contracted
• Work with the client and RBQM Implementation Consultant to define risk controls including key risk indicators
• 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
• Support the client with the development of the overall monitoring strategy, including the centralized monitoring plan
• Performing periodic centralized monitoring review of the Study and Site dashboards to provide insights in study and site risk profile and recommendations for action
• Complete SOP Gap Analysis work where consulting has been sought from clients
• Support the internal sales team as required for client RFPs and bid defense meetings
• Act as internal stakeholder representing clients/end users as part of the OPRA product development cycle.
• 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 every day clinical trial conduct.

This role will also be a stakeholder in the future de