• Manager-DSRM

Industry : Pharma / Biotech / Clinical Research
Location : Mumbai
Qualification : MBBS/MD
Open

Functional: Regulatory Affairs / Product Registration
Job Description
About Us :
Spectrum Talent Management is a comprehensive HR services company offering solutions spanning the entire talent life cycle including Recruitment, Onboarding, Payroll and Flexible Staffing. Founded in 2008, we are a continuously growing, yet mature service firm specializing in recruitment and staffing requirements of global organizations. Our leadership and high acceptance in the market is evident by the phenomenal growth that we have demonstrated in just few years of our inception. From Permanent recruitment to Flexi staffing, Payroll management to RPO, the orbit of the value add that we provide our customers with has always evolved, and diversified from time to time. This has enabled us to become a preferred vendor with most of our clients.
About Company :
A leading pharmaceutical organisation
Roles and Responsibility :

 

Job Description

1.         Provide medical oversight for ongoing clinical studies regarding protocol exemptions.

2.         Checking protocol exemptions,protocol eligibility issues, accepted medications.

3.         Review out of range laboratory values and general medical related study issues.

4.         Medical review of Individual Case Safety Reports (ICSRs)

5.         Preparation and review of study documents (Protocol, IB ,MMP, SMP,CRFs, CSR)

6.         Medical review of clinical trail data, final approver for any medical/ safety query closure.

7.         Points of contact for CRO, study team and sites regarding medical query.

8.         Identify training requirements and provide training to study team including CRO study person.

 

Recruiter Name : Prerna Sharma
Recruiter Number : 8700585944
Recruiter Email Id : s.prerna@spectrumtalentmanagement.com
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