Medical Monitor Vimta Labs Hyderabad
Medical Monitor Vimta Labs Hyderabad
Posted on :
05-04-2025
Employer Active
1 Vacancy
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Job Description
Medical Monitor @ Vimta Labs Hyderabad
Experience: 36 years
Qualification: MBBS / MD with relevant experience.
CTC: 715 LPA
Responsibilities:
- act as medical monitor and interact with site investigators for patients eligibility and SAE documentation and follow up. Coordination with regulatory ethics committee and sponsor for submission of AE/SAE data.
- Collaborates with clinicians site investigators clinical scientists biostatisticians to interpret protocol and study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
- Handle sponsor regulatory and ethics committee queries related to eligibility AE documentation and PV.
- Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical monitoring documents
- Participates in scientific communication planning including development of strategic medical monitoring/ communication plans
Review and edits protocols regulatory documents ICFs CRF/eCRFs and various relevant study plans for efficacy and safety summaries. Review of related clinical documents such as abstracts posters presentations and manuscripts for Clinical Trial/PK PD study design for biosimilars.
- Therapeutic area training of clinical operation team and medical input to DM and statistician team
Interested candidates can share their resumes to
Contact:
Keerthana
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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