Medical Monitor @

2 weeks ago

Hyderabad, Telangana, India Vimta Labs Full time ₹ 7,00,000 - ₹ 15,00,000 per year

Medical Monitor @ Vimta Labs, Hyderabad

Experience: 3-6 years

Qualification: MBBS / MD with relevant experience.

CTC: 7-15 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

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