Clinical Operations Manager
LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
Role & Responsibilities
Clinical Operations Manager - This role will be based at our site in Stirling but will require travel to our Glasgow site. Some travel to clinical sites around Scotland may be required. Some home-working may be feasible.
Permanent / Full-time
The Clinical Operations Manager will lead on operational and logistical requirements for in-house, UK-based and global studies. Studies include sample collection activities to support assay development, formal clinical studies leading to regulatory approval and post-market evaluations. Additionally the Clinical Operations Manager will lead internal phlebotomy activities and management of sample banks.
As part of the development of our products, LumiraDx collects samples from patients under ethically approved protocols at multiple clinical sites in the UK and works with global LumiraDx teams and third parties to manage studies in other countries. The Clinical team are responsible for the design, approval, implementation and management of these studies.
- Establishment of internal procedures for clinical sample shipment, processing, storage and traceability.
- Work with Clinical Study Management and R&D teams to provide appropriate fresh or banked clinical samples for assay development and formal regulatory studies.
- Coordinate with Clinical Study Management team to ensure study supplies are planned into study protocols and timelines
- In conjunction with local LumiraDx Operations and Supply Chain teams, establish and maintain procedures for cartoning, labelling and shipment of Clinical supplies.
- Manage a team of Clinical Technicians, Clinical Study Coordinators and Phlebotomists across Stirling and Glasgow sites.
- Able to establish and maintain excellent relationships with internal teams and external providers
- Understand the relevant clinical requirements from the Clinical Study Management and R&D project teams.
- Collaborate internally with teams including R&D, Medical Affairs, Supply Chain and Marketing.
- Ensure that study supplies are provided and maintained in alignment with internal procedures and global regulatory requirements, for example UN hazard labelling and BS EN 13612 and ISO20916 guidance.
- Ensure that clinical samples are maintained in alignment with internal processes and external guidance, for example Human Tissues Act.
We are looking for a highly self-motivated individual with exceptional attention to detail and high level skills in organisation along with the following experience:
- A Degree in a relevant scientific discipline, or professional qualification such as nursing, or equivalent experience
- Experience of supply chain integration and UK/global shipping requirements
- Receptive to working in a fast-paced, constantly changing work environment.
- Line management experience
- Significant operational experience in Clinical trials/studies preferably with In Vitro Diagnostics or Medical Devices
For further information and to apply for this role, please click APPLY