Clinical Affairs Specialist

6 months ago


Manchester, United Kingdom Novacyt Group Full time

**Job title**:Clinical Affairs Specialist

**Reports to**: Global Head of QA/RA

**Location**: Manchester Science Park / Hybrid working arrangement

**Contract Type**: Permanent / Full-Time

**Salary & Benefits**: Competitive Salary + Benefits Package

**About Yourgene Health**:
Yourgene Health is a leading integrated technologies and services business, enabling the delivery of genomic medicine. Yourgene work in partnership with global leaders in DNA technology to advance diagnostic science.

Yourgene primarily develops, manufactures, and commercialises simple and accurate molecular diagnostic solutions, for reproductive health and precision medicine. Yourgene's flagship _in vitro_ diagnostic products include non-invasive prenatal tests (NIPT) for Down's Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests and DPYD genotyping.

Yourgene also has a global laboratory service network equipped to be a full life-cycle partner for clinical, research and pharmaceutical organisations to support partners at the preclinical, clinical, and post market stage to develop, manufacture, obtain regulatory approval and commercialise new products and services. In addition, Yourgene offers an NIPT testing service in the Manchester laboratory.

Yourgene Health is headquartered in Manchester, UK with facilities in Taipei, Singapore, the US and Canada.

**Our Culture**:
Yourgene is a growing, vibrant and exciting place to work, we are looking for committed driven individuals to be part of our next growth journey. Our culture is described by our employee's as collegiate, friendly, professional, innovative, open and fast paced. We have plenty of social and well-being initiatives run by our Nova Social & Charity Huddle that keep our sense of community alive and allow us to be part of charity fundraisers. At Yourgene, we focus on putting values led programmes in place to ensure that we can attract, retain and develop our people. We want our people to have a career with Yourgene and we ensure that they are recognised and rewarded for their achievements and commitment, everyone plays a critical role in our growth journey.

**About the role**:
We are looking to recruit a full-time and permanent Clinical Affairs Specialist on a hybrid working basis. The Clinical Affairs Specialist will be supporting continuing clinical evidence and clinical benefit for the Yourgene and Novacyt Group clinical portfolio of IVD assays/instruments. The majority of responsibilities include Clinical Performance Studies and Performance Evaluation, with the aim of improving the company’s processes surrounding Clinical Evidence and Performance Evaluation

The individual will ensure sufficient clinical evidence and clinical benefit is achieved for IVD assays and instruments in addition to reviewing/generating new clinical evidence post market where needed in relation to the performance evaluation process.

This individual will be responsible for coordinating and completing Performance Evaluation Plans and Performance Evaluation Reports. Including the gathering of Scientific Validity and State of the Art evidence to support the performance evaluation of IVDR assays. The individual will also be responsible for Post Market activities such as writing and conducting the Post Market Performance Follow Up (PMPF) Plan and Reports, as well as contributing to Post Market Surveillance as a Clinical SME.

The individual will support Marketing where needed and participate in device development from the start, with the insight they will have in market needs (e.g., product demand, target selection, sample type, competitor analysis) as well as regulatory requirements.

**Key areas of responsibility**:

- Completion and management of Performance Evaluation Plans, Reports, and Processes.
- Gathering of evidence to show Scientific Validity and State of the Art for IVDR submissions.
- Management of Post Market activities including PMPF plans and reports, sit as a clinical SME during post market activities.
- Collaborate with the clinical research team to support clinical performance studies for Novacyt’s in-vitro diagnostic medical devices, ensuring compliance with the ISO 20916:2019 standard and IVDR requirements.
- Ensure documentation (protocols, reports, risk assessments, consent forms etc.) is up to date and in compliance with standards and regulations.
- Familiarity with the market needs to support device development. This may involve networking with hospitals and laboratories to investigate which type of products and which pathogens are the most in demand, what sample type is used, and which competitors are on the market.
- Work with RA to ensure the clinical performance study is compliant for the target markets.
- Supporting marketing, to build and strengthen the network of laboratories, hospitals, and Key Opinion Leaders to support planning and execution of state-of-the-art clinical performance studies. Work closely with



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