We are working with an exciting Start-up Medical Device Company who have an opportunity for a Clinical Trial Manager (Contract).
This company has a revolutionary product which is a mix of hardware/software and is set to change the way treatment is delivered to patients, vastly improving quality of life.
A Clinical Trial Manager is required to help establish SOPs for Clinical studies and Clinical research strategy, as well as oversee the undertaking of these Trials, firstly within the UK. The client then plans to undertake Clinical studies in the Netherlands and Belgium next year.
- Establish Clinical SOPs, implement and monitor progress against project plans and revise as necessary
- Create and manage variance to required project plans
- Tracking and reporting on trial progress: Understand the trial delivery strategy, costing assumptions and resulting budget for assigned trial(s) in order to manage vendors
- Monitor trial assumptions, schedule and costs to ensure all remain on track with the contract
- Proactively lead both quality control and risk assurance activities to ensure trial deliverables are achieved
- Act as primary point of sponsor contact for sites. Escalate issues as needed to appropriate stakeholders
Qualification and Experience
- Clinical Trial Set-up
- Clinical Trial Management
- Experience of hardware/software medical device