Clinical Study Delivery Coordinator

Owlstone Medical Ltd is on a mission to save 100,000 lives. To achieve this, within Clinical Study Delivery we support a number external customer clinical projects to discover biomarkers associated with disease and we are now looking for a highly organised and self-motivated Study Delivery Coordinator to join our team.

This is an external facing role, supporting and co-ordinating all study activities from set up of the documentation, initiation and training of the sites, monitoring of sample collection, through to supporting the internal analysis of samples, closing sites and reporting back on the findings.

This role will require international travel to support training of sites on our technology. When not travelling, this role is onsite at our Cambridge offices.

Key Tasks and Accountabilities

You will be responsible for all the documentation, equipment and site set up for your assigned studies including those tasks typically carried out by other members of the Customer Study Delivery team.

You will be responsible for the following:

• Customer and site communications from study set up until close out
• Ensuring quality of sample collection, receipt and data
• Accurate tracking and reporting of costs and timelines
• Preparation, management and review of study documentation

• Ensuring the right equipment is available, tested appropriately and shipped to the site
• Conduct of a project kick off meeting with internal and external customers
• Providing training (in person at clinical sites) and documentation on breath sample collection
• Input into study contracts and review of clinical protocols

• Lead study review meetings to discuss recruitment and study design with internal and external customers
• Visit clinical sites to review the accuracy of sample collection and provide additional training and support as required
• Monitor recruitment at sites and report on status and deviations from expectations
• Check sample quality and request repeats where required
• Study logistics with regards to ordering, provision and on time delivery of study equipment and consumables and take responsibility for troubleshooting issues
• Interface with internal teams to ensure consumable requirements are understood and accounted for during the lifecycle of the study

• Responsible for ensuring sites are closed out appropriately and all equipment returned promptly
• Support data analysis and interpretation with input based on customer expectations and sample collection / recruitment knowledge

• Be responsible for training more junior staff and provide induction training for new starters
• Provide guidance on management of documentation
• Responsible for peer review of completed documentation and QC check of documentation for delivery to external sites and customers

• Ensure that all decisions are documented and that all records and documentation are accurate and stored appropriately according to the appropriate SOPs and provide stakeholder reports as required
• Raise and log non-conformances and contribute to CAPA investigations and implementation of improvements
• Highlight gaps and contribute to updates and reviews of departmental SOPs

Requirements

• Experience in Clinical Study Delivery
• Experience in working with customers and / or clinical sites
• Experience of maintaining study documentation
• Further education in a technical or science discipline or equivalent experience
• Experience of Good Clinical Practice
• Excellent written and verbal communication skills and be comfortable interacting with a wide range of people.
• Confident in using Microsoft Office tools

• Experience of setting up and training clinical sites
• Prior experience of coordinating clinical trials in Africa
• A good awareness of the regulatory issues and requirements surrounding clinical trials and research studies
• Experience of working within an ISO 9001 Quality Management System and/or clinical trials regulated environment

Benefits

About Owlstone Medical

Owlstone Medical’s vision is to save 100,000 lives by realizing the enormous promise of breath-based diagnostics through the development and application of Breath Biopsy®, a unique platform capable of both biomarker discovery and use in routine clinical testing.

The Company’s technology is protected by over 160 granted and pending patents and has been used in more 100 research papers.

Projects are supported by Breath Biopsy OMNI®, the most advanced solution for reliable end-to-end global breath VOC analysis, which is helping researchers advance biomarker discovery and disease research and maximizing the chances of finding clinically relevant breath biomarkers.

The Company has a portfolio of Breath Biopsy tests in development for the early detection of lung cancer and liver disease, both areas of high unmet clinical need that represent multi-billion dollar market opportunities. In digestive health, under the OMED Health brand, clinical tests for Small Intestinal Bacterial Overgrowth and carbohydrate malabsorption are on market in the U.K., and a handheld device and app for longitudinal monitoring of digestive health has recently been launched.

We offer a relaxed, friendly, flexible and international working environment with a strong and vibrant team-spirit. If you want to experience the buzz of a thriving start-up company set to succeed on a global scale, Owlstone Medical could be the place for you.

We do not accept applications from agencies outside of our preferred supplier list. If you are concerned that your application has not been received by Owlstone Medical, please contact us using careers@owlstone.co.uk