- Experts on both Neonatal/ Paediatric & Critical Care Products.
- Very low staff T/O.
- Year on Year Growth.
- Opportunities within the company to progress.
- To set up, support and monitor clinical trials, ensuring investigators are working within the requirements of the clinical protocol.
- To provide clinical support to the Regulatory Affairs and Research and Development teams and for Product Management/Marketing both pre- and post-market across the Company’s portfolio.
- To assist in the development of new products and to be aware of clinical trends and opportunities.
- Support the implementation of the clinical research strategy for the Company’s products.
- Keep up-to-date with developments in clinical research and the clinical literature in the Company’s key therapeutic areas.
- Provide input into clinical trial protocols to ensure that the Company’s research objectives are met.
- Organise and support clinical studies/trials in order to build data and supporting evidence for product registrations.
- Support and contribute to the preparation and submission of documentation for approval of clinical. investigations to regulatory authorities, healthcare provider Research and Development officers and research ethics committees.
- Monitor clinical trials, in which the Company has a direct role, in accordance with good clinical practice (GCP) and provide regular feedback to Company personnel on the progress of trials.
- Build relationships with medical professionals and key opinion leaders.
- Maintain the highest ethical, clinical and scientific standards, ensuring the safety and well-being of all trial participants and good/rigorous scientific practice.
- Keep well-informed of international legislation and requirements concerning clinical research.
- Maintain surveillance of clinical publications of relevance and disseminate appropriately relevant points.
- Develop clinical training materials and help with the clinical applications and teaching support for the products.
- Assist with answering clinical queries from regulatory bodies, customers, sales teams etc.
- Work closely with internal departments to support development of relevant sections of marketing requirements for product development.
- Participate in the risk analysis of new products to ensure that clinical applications and the risks associated with the device are understood.
- Create and deliver detailed clinical evaluation reports for new products.
- Provide input into testing, such as biocompatibility, from a clinical use perspective.
- Facilitate the organisation of the product usability / human factors study including creating protocols and questionnaires, and working with external agencies where appropriate.
- Clinical input into the complaints process for reportability decisions and develop health hazard assessments and evaluations accordingly.
- Liaise closely with Quality Assurance and provide input into Serious Adverse Events (SAE) and regulatory reporting of the Company’s products.
- Update existing clinical evaluation reports for products already on the market, due to change of circumstances, e.g. complaints, adverse incidents, new clinical data, and especially in regard to clinical risk.
- Ensure all clinical references on marketing material are appropriate and referenced correctly.
- Responsible for clinical compliance and governance of MDR.
- £35k- £60k basic salary + 25 days’ holiday plus public holidays; workplace pension scheme with Royal London - 5% matching contributions; life assurance / death in service of 3 x basic salary; access to engagement platform for retailer discounts and cashback; Simplyhealth healthcare cash plan – post probation; Cycle to Work scheme – post probation; Sharesave scheme – post probation; Employee assistance programme.
The Ideal Person:
Clinical Affairs Lead or Associate - Neonatal
- Educated to at least degree level in a relevant discipline and/or demonstrable success in a similar role.
- Healthcare / medical device industry background.
- Minimum of 2 years’ experience of clinical affairs working preferably with medical devices.
- Complete start to finish experience of clinical trials (i.e. from concept to final documentation).
- Knowledge of the Neonatal Intensive Care environment.
- Interaction with Clinical Research Organisations.
- Experience of working with Clinicians, Healthcare provider R&D Officers, Research Ethics Committees and regulatory bodies (e.g. MHRA).
- International clinical experience in the above.
Key Skills and Competencies
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