Clinical Lead, home based at IQVIA

The Role

As Senior Clinical Lead with IQVIA, you are a member of our core project team. Partnering with the Project Leader you will work strategically and collaboratively to achieve clinical operational delivery excellence, representing clinical delivery with the customer.

You will be responsible for running international/global studies in all therapeutic areas, managing the operational aspects of projects to meet contractual requirements. Using our innovative and cutting-edge in-house technology you’ll be key to improving the efficiency of our global trials.

RESPONSIBILITIES OVERVIEW

Clinical Delivery

• Partners with the Program/Project Lead to ensure timely and in scope clinical delivery.
• Developing the monitoring plan and data cleaning strategy, including risk-based monitoring. Manage clinical study set-up, maintenance and follow-up study activities through ongoing tracking and review of study progress. Report progress to appropriate clinical management and project management forums. Managing the visit report.
• Drive patient recruitment using the most advanced technology and tools, with a data driven approach.
• Vendor support.
• Participating in pre-award preparation activities, attending and presenting at kick-off and investigators meetings.
• Readily adapts to changes in project environment and able to take positive actions to minimize impact to projects. Takes responsibility for actions, projects and people.

Project Quality

• Developing risk mitigation and plan. Ensure timely CAPA’s and issue closure. Oversee the implementation of clinical study documents and ensure TMF inspection readiness. Provide audit support and issue management oversight

Clinical Training and Resources

• Responsible for clinical team resources and project related performance. Delivering project-specific trainings and providing therapeutic area training support. Creating study tools and maintaining these. Provides others with clear direction, delegates work appropriately and fosters learning and knowledge sharing between colleagues.

Clinical and Data Management Progress

• Drive successful data cleaning in close collaboration with Data Management. Produce clinical oversight metrics and act as clinical point of contact for the team. You will be client facing and representing clinical delivery with customers.

Financial Support

• Overseeing budget and variances compliance. Maintaining scope and finance systems. Responsible for tracking financial deliverables, reporting and invoicing on projects.
• You will need to be comfortable working closely with customers and senior colleagues across the business, mentoring junior colleagues and where appropriate, influencing decision making at all levels.  

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s degree in a healthcare or other scientific discipline with at least 7 years in clinical research/monitoring experience or equivalent combination of education, training and experience. To include a minimum of 3 years leading projects (this can be as a project manager or clinical leader).