The Clinical Evaluator identifies specific aspects of the clinical data evaluation for their specific review. During clinical evaluation, they should verify:
RA & Clinical Evaluation Associate
1 Nos.
31995
Full Time
1.0 Year(s) To 3.0 Year(s)
2.40 LPA TO 3.00 LPA
Production / Quality / Maintenance
Medical/Healthcare/Hospital
Job Description:
- If the benefit/risk profile, undesirable side-effects (whether previously known or newly emerged) and risk mitigation measures are
- Able to prove the safety and performance of the device
- Correctly addressed in information materials
- Addressed in the current PMS Plan
2. If the risks are acceptable when compared with the benefits
Requirements to act as Clinical Evaluator
- The clinical evaluator must have training and experience in relevant fields corresponding to the device under evaluation.
- The clinical evaluator must have knowledge of the device technology and application; and also the diagnosis and management of conditions intended to manage or treated by the device, medical alternatives, and treatment standards.
- They should be able to assess the degree of relevance of papers selected through a Literature search .
- They should also be able to differentiate if the relevant data is useful for the application or use of the device.
Clinical Evaluator also should:
- Identify information contained in each document,
- Evaluate the methodological quality of work done by the authors and from that, the scientific validity of the information,
- Determine the relevance of the information to the clinical evaluation, and
- Systematically weight the contribution of each data set to the clinical evaluation.
- Set the plan for appraisal of the clinical data to conduct a thorough and objective appraisal of clinical data.
- Responsible for conducting the appraisal by evaluating the methodological quality and scientific validity.
- Examine the methods used to generate/collect the data and evaluate the extent to which the observed performance or safety outcomes can be attributed to the intervention with the device.
- Verify whether clinical investigations have been defined to confirm or refute the manufacturer’s claims for the device; and whether these investigations guarantee the scientific validity of the conclusions by including an adequate number of observations.
- Involve with the analysis of the clinical data by identifying appropriate criteria to be applied for a specific evaluation to demonstrate the compliance of the device to GSPR.
- Identify additional clinical investigations or other measures that are required to generate any missing data and eliminate compliance issues.
- Perform post-market activities like PMS, PSUR, and PMCF in association with other team members.
- Conduct PMCF – the clinical evaluators should identify residual risks, any uncertainties, or unanswered questions.
Key Skills :
Company Profile
One of the leading manufacturers of surgical appraratus especially in the Opthalmic field. One of the biggest IOL Manufacturer from INDIA.
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