Clinical Data Analyst III

Job Title: Clinical Data Analyst III

Location: Rochester, NY 14626

Duration: 1 year

Responsibilities

• The Responsibilities: Based on the classification assessment of the Ortho 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.

Qualifications

Experience

• 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.

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.

Kind Regards,

Sabanaaz Shaikh

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

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