Clinical Data Analyst III

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.

Requirements

• 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
• Gold Seal JCAHO Certified ™ for Health Care Staffing
• "INC 5 0 0 0 's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)

Benefits

Additional Information

Job Title: Clinical Data Analyst III Location: Rochester, NY 14626 Duration: 1 year

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