- Ensure data availability for algorithm testing as per specifications, suggesting enhancements, collecting additional data, and maintaining data quality.
- Possess a hands-on background in data science, comprehending quality and regulatory standards.
- Spearhead data collection initiatives in clinical settings akin to clinical trials, aiming to validate hypotheses, identify data trends and patterns, and forecast for product enhancements.
- Manage data produced during development and validation of the technology, ensuring efficient use and consistency throughout, ensuring we draw the right conclusions and make the right decisions regarding the product. "Data" in this sense is predominantly in the form of images (and their associated metadata) captured by our device, which are then processed by our proprietary image processing software and algorithms to arrive at a conclusion (infection status, identification of bacteria, which antibiotics might be suitable) which is then reported as a result to the user. The data could also be in the form of readings from different instruments used to develop the assay.
- Maximise the potential value of the data that is produced by the PoC test when operated at testing / user sites, such as infection rates, and patterns in types of bacteria causing infection and antibiotic resistance. This will include ensuring that data reporting is done in a format compatible with lab / hospital information systems. There are specific challenges associated with this (incl. GDPR/ HIPAA confidentiality, security, connectivity limitations [e.g. many clinics prevent connection of machines to their network, and mobile data communications may not be feasible]). Hence, the candidate will ideally have experience in developing similar products for medical use locations such as hospitals.
- Management of data sets obtained through pre-clinical and clinical studies. Note this would typically be co-ordinated with the support of a CRO, but knowledge of this process would be beneficial. Also, direct management and statistical analysis of analytical data sets (generated in-house) as well as verification planning and testing would be involved.
- Overall, efficient use, consistency and quality throughout in reporting and assessing the suitability of our data to support verification and validation of the product's requirements.
- Operating under change management and CAPA systems when in appropriate stages of development.
- Work in accordance with 21 CFR part 820, ISO 13485, ISO 14971, IVDR, and other applicable regulations. Knowledge of IEC 62304 would also be advantageous.
- Ensure the executive team is kept up to date with engineering-related issues, reporting progress on a regular basis.
- Promote a positive working environment and foster teamwork.
- Recognised degree in a relevant discipline such as Mathematics, Computer Science, or Engineering
- At least 5 years of work experience in roles involving the management of data, including as many of the following as possible:
- Work experience gained through the development of a medical device, ideally an IVD;
- Experienced in the organisation and statistical analysis of data generated from clinical studies;
- Taken a medical device through V&V, with FDA and/or CE approval and launch;
- Been involved in ongoing maintenance or data collection from instruments or machines placed in testing locations (e.g. clinics), possessing a good understanding of the challenges and security concerns surrounding data obtained from these settings.
- Proactive and enjoy working as part of a small professional team
- Good working knowledge of the MS Office Suite and relevant data processing software
- £50-80k, DoE
- 30 days holiday + bank holidays
- Employee Health cash plan / Health Insurance
- Company Pension Scheme (up to 5% employee, 10% company contributions)
- Travel Insurance (personal and business cover)
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Description
CAPU Search is proud to be partnering with a PoC Diagnostics start-up based in the South West of England to find a Data Manager to join their growing team and become the intermediary between Software, Biology and Quality.
Location: South West, UK - Hybrid (2-3 days in the office preferred)
Contract: Permanent, full time
Hours: Core hours 9am - 5pm with flexibility as required
Mission:
Our mission is to radically transform the way bacterial infections are diagnosed to drastically improve patient care. We are developing a rapid, point-of-care, urinary tract infection diagnostic system which can suggest the correct antibiotic treatment within 60 minutes versus the multi-day wait it currently takes. We are a small team of ambitious scientists, engineers and business experts who are all passionate about bringing game-changing healthcare technology to market.
We are looking for a reliable person who is competent and capable of taking on the responsibility of their own workflow from an early stage. There may be the opportunity to manage and recruit a larger engineering team in the future. We are a small, young and dynamic company and as such, there is scope for an ambitious candidate to grow the role over time to support other areas of the business as needed.
Short/Medium Term:
Longer Term:
Key responsibilities will include:
Skills and qualifications required
Salary and benefits