Clinical Affairs Lead or Associate - Neonatal

Posted 30 March by On Target Recruitment
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The Company:

  • Experts on both Neonatal/ Paediatric & Critical Care Products.
  • Very low staff T/O.
  • Year on Year Growth.
  • Opportunities within the company to progress.

The Role:

  • 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

Mandatory

  • 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.

Desirable

  • 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

  • Good understanding of clinical study design and management.
  • Working knowledge of international regulatory requirements applicable to clinical research;
  • Strong awareness of research ethics.
  • Thorough understanding of the importance of good clinical practice (GCP).
  • Clinical interest and ability to interpret clinical information.
  • The ability to develop strong business relationships and work successfully alone and in a cross-functional team.
  • A flexible attitude and the determination to see projects through to their conclusion.
  • Good organisational and documentation skills with a methodical approach and the ability to convey data clearly and concisely.
  • An enquiring and analytical mind with exceptional attention to detail.
  • The ability to manage priorities and work to tight deadlines under pressure.
  • IT literate and the ability to use different software packages and communication tools.
  • Excellent interpersonal, communication (written and oral) and presentation skills.
  • Evidence of teaching and supporting/mentoring colleagues.The willingness and flexibility to travel within the UK an
  • Reference: 42368180

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