Metabolomic Diagnostics Ltd are currently recruiting a Clinical Affairs Manager to join our team. The position is a senior role within the management team.
Clinical Study Support:
- Assist in defining and developing clinical research strategy and study protocols.
- Lead and execute clinical research studies and programs with Academic and/or Clinical Institutions: Observational studies, Verification and Validation studies, etc.
- Lead Institutional Review Boards processes
- Manage clinical study site relationships and external CRO’s when applicable.
- Maintain operations to ensure compliance with protocol and applicable regulations.
- Assist with data analysis and reporting as appropriate.
- Create and document relevant policies and Standard Operating Procedures (SOPs) for clinical operations as appropriate.
- Monitor relevant scientific literature and competitor’s dissemination activities and compile regular updates for management team.
Medical Communications / Publications:
- Direct, and actively contribute to the clinical-scientific dissemination of the company’s translational research and IVD development studies in abstracts, posters, conference presentations, peer-reviewed manuscripts.
- Provide support for disseminating the company’s research and development progress to various stakeholder groups like clinicians, patients, general public.
- Provide support in raising the company’s expert status in the domain of diagnostic solutions for pregnancy complications by selecting, and possibly discussing, relevant 3rd party content for the company’s communication channels.
- Assist in the development of a communication tool set, inclusive clear and consistent language to describe the company’s product development strategies and results.
- Act as the company’s clinical expert in 3rd party engagements and at clinical forums.
Strategic inputs and Exploitation:
- Assist in the formulation of User Needs and the Clinical Use Cases and their translation into future Product Requirements.
- Capture the Voice of the Customer by appropriate engagement with practising clinicians, patients, health care systems etc.
Essential Requirements necessary to carry out the role effectively:
- Degree in one of the following disciplines or equivalent: Medical Degree (preferably in obstetrics, maternal-fetal-medicine), Biomedical sciences, Translational Research, Biostatistics and Epidemiology, Public Health.
- Knowledge of US and EU Regulatory Requirements for (IVD) Medical Devices, Good Clinical Practice.
- Understanding of requirements for conducting clinical studies.
- Prior experience in desk-based research.
- Prior experience in writing scientific papers, published in peer reviewed journals.
- Strong verbal and written communication skills.
- Ability to engage constructively with stakeholders to communicate developments.
- Capable to work without direct supervision within a team environment.
- Ability to motivate and effect change.