Job Purpose

• Oversee client relationships Support client Account Management activities Ensure quality and timely implementation of the product (OPRA CM & RAM)
• Conduct consulting project work as required by RBQM Operations Management
• Participate as business SME in Product Development workstreams

Key Functions

The key functions performed by the Senior RBQM Operations Consultant will include, but may not be limited to the following areas:

• Training and mentoring new RBQM Operations Consultants particularly in central monitoring/risk management approaches
• Oversight/peer review of work by RBQM Operations Consultants
• Potential for Line management, if assigned
• Support development of internal process and training Client relationship management
• Responsible for assigned clients and oversight of all client deliveries
• Attendance at governance meetings
• Reporting on future work requirements
• Maintaining client level project documentation and processes Project Management
• SoW ownership
• Primary point of contact with client
• Delivering projects to defined timescales
• Management of project plan, budget and renegotiating statements of works
• Coordinating cross    functional         team    g.            Implementation, Development, Test, Validation, in project delivery
• Working across multiple projects and clients simultaneously

OPRA Implementation and Centralized Monitoring 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 to define risk controls including key risk indicators
• Work with the client to define key risk indicators e.g. what does it measure, what questions are you answering, what is the critical thinking around the route cause analysis
• Support the client with the development of the overall monitoring strategy, including the centralized monitoring plan
• Train client on the use of the OPRA application
• Support client in the conduct of periodic centralized monitoring review of the Study and Site dashboards, to provide insights in study and site risk profile and recommendations for action

RBQM Consulting

• Complex consulting activities including e.g. full client organization change management relating to RBQM
• Complete SOP Gap Analysis work where consulting has been sought from clients
• Update/create SOPs to support identified gaps
• Facilitate client stakeholder reviews
• Support clients in conducting and documenting protocol risk assessments
• Support clients in creating Integrated Strategic Monitoring Plans (ISMP)
• Support clients in creating Monitoring/Centralized Monitoring Plans
• Creation of new consulting materials related to assigned consulting projects
• Creation of new consulting materials to support future projects OPRA Development
• Act as internal stakeholder representing clients/end users as part of the OPRA product development cycle
• Support the development of end user requirements for new features
• Support the review of Product Proof of Concepts (POCs)
• Support demonstration of new features to clients
• Support the development on new processes and training materials to support new features
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Sales and Marketing support

• Support the internal sales team as required for client RFPs and bid defense meetings
• Support internal marketing team with the development and delivery of webinars
• Keep up to date with industry regulations and support in the identification potential areas in new/forthcoming changes for new consulting opportunities

Skills and Qualifications

• Degree or Postgraduate degree in relevant scientific discipline OR equivalent experience
• 10 years industry experience in a relevant clinical trial role, Central Monitoring or Risk Management (required)
• Self-motivated
• Strong communication and influencing skills both internal and external stakeholders
• Strong project management skills Ability to prioritise and multi-task Enjoy working in a small team
• Contract and Budget Management experience preferred

How to apply

Please send your CV along with a covering letter to info@tritrials.com