Clinical Data Analyst

Clinical Data Analyst

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

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.

Qualifications

• 5+ years' experience in a role in regulated healthcare industry and preferably in a Medical Device/IVD regulated industry.

• Preferable experience having worked in an R&D or Clinical Affairs role.