RA & Clinical Evaluation Associate Job Vacancy in Mantras2Success consultants Ahmedabad, Gujarat – Latest Jobs in Ahmedabad, Gujarat
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Company Name : Mantras2Success consultants
Location : Ahmedabad, Gujarat
Position : RA & Clinical Evaluation Associate
Job Description : Opening: 1 Nos.
Job ID: 31995
Employment Type: Full Time
Reference:
Work Experience: 1.0 Year(s) To 3.0 Year(s)
CTC Salary: 2.40 LPA TO 3.00 LPA
Function: Production / Maintenance / Quality
Industry: Medical/Healthcare/Hospital
Qualification: Any – Any Graduation
Location:
Ahmedabad
Gandhinagar
Job Description:
The Clinical Evaluator identifies specific aspects of the clinical data evaluation for their specific review. During clinical evaluation, they should verify:
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 :
Qms
Iso 13845
Documentation Executive
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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