Medical Monitor @ Vimta Labs, Hyderabad

Vimta Labs Ltd; Hyderabad; On-site; INR 7,00,000 - 15,00,000; Full time

Job summary

An established industry player is seeking a Medical Monitor to join their dynamic team in Hyderabad. This role involves crucial responsibilities such as interacting with site investigators, ensuring patient eligibility, and managing serious adverse event documentation. You will collaborate closely with a variety of professionals, including clinicians and biostatisticians, to interpret protocols and study results accurately. Additionally, you will be responsible for creating compliant medical monitoring documents and participating in scientific communication planning. If you are passionate about clinical research and have the necessary qualifications, this opportunity could be the perfect fit for you.

Qualifications

• 3-6 years of experience in medical monitoring and clinical trials.
• MBBS/MD with relevant experience in medical documentation.

Responsibilities

• Interact with site investigators for patient eligibility and SAE documentation.
• Collaborate with clinicians and biostatisticians to interpret study results.

Skills

Medical Monitoring

Patient Eligibility Assessment

Regulatory Compliance

Scientific Communication

Education

MBBS

MD

Job description

Medical Monitor @ Vimta Labs, Hyderabad

Experience: 3-6 years

Qualification: MBBS / MD with relevant experience.

CTC: 7-15 LPA

Responsibilities:

1. 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.
2. Collaborate with clinicians, site investigators, clinical scientists, and biostatisticians to interpret protocol and study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents.
3. Handle sponsor, regulatory, and ethics committee queries related to eligibility, AE documentation, and PV.
4. Create and maintain standard operating procedures and work instructions for preparation and maintenance of compliant medical monitoring documents.
5. Participate in scientific communication planning, including development of strategic medical monitoring/communication plans.

Review and edit protocols, regulatory documents, ICFs, CRF/eCRFs, and various relevant study plans for efficacy and safety summaries. Review related clinical documents, such as abstracts, posters, presentations, and manuscripts for Clinical Trial/PK PD study design for biosimilars.

1. Conduct therapeutic area training of the clinical operation team and provide medical input to the DM and statistician team.

Interested candidates can share their resumes to [e-mail]

Contact:

Keerthana

9160712930