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
Senior Clinical Programme Manager - based out of our offices in Central Scotland but with some home working, travel will be required
Full time - Permanent
Working as part of the Clinical team you will have significant clinical project responsibility for planning and conducting all clinical studies to support product development, regulatory submissions and post-market evaluation for In Vitro Diagnostic products on the LumiraDx Platform. Studies will range from single site to international multi-centre so some travel will be required.
The role will plan, implement, monitor and review studies in line with our business plan whilst meeting all ethical, regulatory and scientific needs. You will also be charged with ensuring the quality and integrity of data, compliance with relevant business processes and regulatory requirements and study completion on time and within budget.
- Technical lead for ensuring clinical trial study design meets the needs of the product launch plan.
- Identify appropriate clinical sites and manage effective clinical relationships. Liaise with the Principal Investigator and clinical operations staff as required.
- Organise/prepare/attend investigator meetings as required.
- Prepare, edit, review and submit clinical documentation according to study needs including but not limited to Ethics Submissions, R&D Applications, Protocols & Protocol Amendments, Case Report Forms, Patient Information Sheets, Consent Forms and Training Materials
- Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required e.g. IRAS, HRA and R&D submissions.
- Clinical lead to ensure studies are planned, implemented, conducted, monitored and reported according to all business processes.
- Monitor clinical trials to ensure compliance to the study protocol, clinical business processes, applicable regulations and the principles of ICH-GCP, typically 50% of active sites.
- Management of clinical sites to ensure protocol, source data verification and CRF compliance.
- Lead pre-study initiation, interim monitoring and close out visits as required.
- Prepare, monitor and report clinical study budgets.
- Provide continuous up-date of trial status to relevant key stakeholders, identifying potential delays that may impact product launch.
- Train external clinical users on the LumiraDx Platform and other relevant products.
- Update and review business processes and clinical procedures to meet regulatory and business needs.
- Responsible for ensuring that all clinical trial master files are "audit ready" at all times.
- Establish and manage effective clinical and/or supplier relationships.
- Understand the relevant clinical requirements; liaise with cross functional team leaders to provide robust clinical outcomes.
- Be solution focused and work as part of a multidisciplinary team to proactively meet and balance the business objectives and clinical requirements.
To be successful in this role you must be a highly motivated individual that can demonstrate flexibility and a can-do attitude. You should ensure positive, productive and proactive relationships with a range of internal and external key stakeholders. You should also have the following skills and experience
- A Degree in Life Sciences, Health Sciences or related field, or professional qualification such as nursing, or in-depth experience in performing a Clinical Research Associate role preferably with Medical Devices or In Vitro Medical Devices.
- Proven and demonstrable experience as a CRA within either Pharmaceutical or In Vitro Medical Devices
- Relevant experience within either a hospital, medical/research centre environment, Contract Research Organisation or Pharmaceutical company.
- Ability to independently create and drive the development of clinical trial related documents and materials.
- Ability to independently perform pre-study initiation, interim monitoring and close out visits as required.
For further information and to apply for this role, please click APPLY