Please note this is a remote-based role, however ideally, you will be based in either Johannesburg, Cape Town or Durban – or within commuting distance from either of these cities.
LumiraDx is a global company with headquarters in the US and UK. We are a dynamic diagnostics company with over 1,000 employees developing breakthrough medical devices and connectivity solutions. We are committed to advancing health care through innovative diagnostic products and connected care solutions. The company is significantly expanding as it prepares to launch an innovative, next generation diagnostic platform, and is looking for a dynamic, experienced Clinical Trials Manager to support and manage all African clinical trials.
The key objective of this role is to lead and manage the African clinical trials. The role supports product development, clinical trials, and post market clinical activities. The Job Holder will manage the scientific strategy centric to all African studies and clinical trials to ensure that they are supportive of business objectives (as directed by the Global Clinicals Team). The Job Holder has responsibility for the timely delivery of quality clinical trial data to support product development, regulatory submissions and post market evaluation of the LumiraDx products while meeting all ethical, and regulatory requirements. The Job Holder will manage the activities of our CRO(s), with the longer term intention of building an African Clinical trials capability. The Africa Clinical Trials Manager reports directly to the Head of Clinical & Medical Affairs (global programme).
Key Areas of Responsibility
- The establishment of a small Africa Clinical Trials Group including identification of suitable facilities and staff, and working with CROs as required.
- Ability to prepare, present and negotiate clinical strategies with CROs, as needed and assisted by Global Clinical team.
- Liaison with LumiraDx Global Clinicals programme to ensure activities are fully aligned with overall LumiraDx strategy, delivery plan and timings for the LumiraDx platform and products.
- Building strong links and relationships with KOLs and clinical researchers to enhance LumiraDx’s position and access to potential African clinical trial sites.
- Establishment of internal procedures for clinical trial management in Africa aligned with global Clinical and Quality Management system. This includes creation and maintenance of all clinical trial files, and file templates, including the trial master file, and oversight of all clinical site/CRO files. This must be compliant with IVDR (and other regulatory bodies as required), LumiraDx Quality management procedures and any local regulatory, quality or clinical requirements.
- Selection and qualification of clinical trial sites and Chief/ Principal investigators (PI).
- Selection, qualification, and management of CROs as required.
- In cooperation with Global Clinical Affairs, develop clinical trial protocols and guidance of those protocols through the ethical approval process.
- Set up, and deliver site initiation visits at the clinical trial sites, including training on patient recruitment, proper sample collection, documentation, data generation and reporting.
- Make or direct regular monitoring visits to clinical trial sites and clinical investigators/PIs. Issue supplies, such as case report forms and investigational product (IUO). Regularly evaluate the quality of case reports and collaborate with clinical trial investigators/PIs to write final technical reports in a timely manner.
- Work with PIs to achieve adequate recruitment and timely delivery of quality clinical trial data, with continuous attention to recruitment rates and strategies to meet company deadlines.
- Coordinate and assist with the preparation and internal publication of study and clinical trial data, reports and information, ensuring that the data presentation meet legislative, contractual and ethical requirements.
- Work as team member of the Global Clinical Team, participating in regular meetings, presenting progress updates, and ensuring compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements.
- Support Medical Affairs in Post launch studies as requested.
- Manage the African Clinical Trials team, setting objectives aligned to company clinical strategy and agreement of development plans for individuals.
- Strengthen the local Clinical Group capability within the overall LumiraDx Global clinicals capability.
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
- BS/BA or PhD Degree in biomedical, life science or healthcare field or clinical qualification such as MD.
- Previous experience as a CRA / Senior CRA / other significant experience and training in clinical trial research.
- Significant international clinical trials experience in the medical device industry (IVD is preferred).
- Direct managerial experience with a Clinical Trials teams.
- Ability to work effectively on multiple projects in varying global locations simultaneously.
- Excellent written and verbal communication skills.
- Adaptable and able to work in an environment where priorities are constantly changing
- Ability to deliver the entire product pipeline from development clinics to full regulatory approval.
- Experience of CE marking/WHO prequal studies for IVD
- Established clinical network in the region.
- Proficient with Microsoft Office Word, Excel, and bio-statistics.
- Ability to work independently and effectively prioritize responsibilities.
- Possess a valid driver’s license.
- Possess a valid passport and be available for independent domestic and international travel as directed.
- Experience of managing regulatory trials for point of care tests or self-testing diagnostics for CE marking/WHO prequal approval.
At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business
Please note, if you wish to submit an application for this role, please consider the following information:
This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.
Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject. LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.