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 keerthana.rojanala@vimta.com

Contact:

Keerthana

9160712930