Clinical Data Analyst

On-siteMidData Analystposted 113mo ago

✦Role summaryAI-generated

This role focuses on evaluating clinical and technical data for in-vitro diagnostic (IVD) products, requiring expertise in regulatory compliance and hands-on assessment of product classifications. The position demands precision in documentation and collaboration with stakeholders to ensure adherence to EU IVD regulations while analyzing sample datasets.

Skills required

Clinical data review Ivd regulatory knowledge Sharepoint Microsoft office Adobe software Data assessment Attention to detail Problem solving Technical writing

About this role

Duration: 12 Months + Contract

SUMMARY OF POSITION:
Required Competencies:

• Experience in technical and clinical data review.

• Attention to detail and problem-solving.

• Excellent verbal, written and presentation skills.

• Ability to work independently.

Desired Competencies: • Working knowledge of EU IVD regulations.

• Working knowledge of IVD products and regulations.

• Familiarity with web-based content sharing applications (i.e. SharePoint), Microsoft Office Suite, Adobe.

Responsibilities:
Based on the classification assessment of the client’s products undertake an assessment of a sample of different classes of product against the Technical Documentation (Annex II - 2017/746) and identify any gaps and in particular significant gaps. From the representative product sample identify the time and resources required to address any gaps that can be used for budget planning purposes in 2018/19, particularly if product testing or performance evaluations are required. Create draft Performance Evaluation reports for a representative sample of Class B, C and D products. Propose opportunities for filling any identified gaps with data from other sources such as published literature, post-market data. Provide periodic updates to the IVDr Project Lead at a frequency to be determined.

Comments/Special Instructions:
Candidates with knowledge of EU IVD Regulations is a plus.