Medical Monitor

6 days ago

Hyderabad, Telangana, India Shilpa Medicare Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Role & responsibilities

  • Provide comprehensive medical and scientific expertise and oversight for clinical trials, ensuring study integrity and participant safety.
  • Review and contribute medical input to study protocols, ensuring clinical feasibility, scientific rigor, and compliance with regulatory requirements and guidelines.
  • Ensure strict adherence to clinical trial protocols through continuous monitoring and proactive management of ongoing studies.
  • Prepare, critically review, and approve essential clinical trial documents across all phases, including Informed Consent Forms (ICF), Statistical Analysis Plans (SAP), Clinical Study Reports (CSR), Safety Management Plans, Medical Management Plans, Case Report Forms (CRF), Investigator Brochures (IB), and related documentation.
  • Evaluate and manage clinical safety data by reviewing adverse events (AEs), serious adverse events (SAEs), and other safety-related information, contributing to timely risk assessments and patient protection.
  • Support the development of medical writing materials, scientific presentations, and publications to disseminate clinical study findings effectively.
  • Collaborate closely with cross-functional internal teams, clinical investigators, regulatory authorities, and relevant external stakeholders to facilitate efficient study conduct and regulatory compliance.

Prepare and review regulatory submission documents, including Scientific Advice requests, Pre-IND packages, Controlled Correspondence, and other essential regulatory communications to support product development and approval processes

Preferred candidate profile

  • Medical degree (MBBS, MD or equivalent) with relevant clinical experience in various therapeutic areas.
  • Strong understanding of clinical trial design, and execution.
  • Ability to critically evaluate medical and scientific data.
  • Excellent communication skills.
  • Experience in pharmaceutical industry clinical research is preferred.
  • Familiarity with safety data management and pharmacovigilance is favored

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