Instagram
youtube
Facebook

Medical Monitor

2-5 years
Not Disclosed
10 Jan. 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Title: Medical Monitor
Location: Bangalore
Date: 21 Dec 2024

Job Description:

The Medical Monitor is responsible for supporting clinical trial-related projects in various therapeutic areas, including medical review, assessment, and interpretation of clinical and safety data to ensure accuracy and compliance with regulatory and SOP requirements. Key responsibilities include preparation and review of protocol-related documents, SAE narrative generation, quality review, and managing clinical trial safety data.

Key Responsibilities:

  • Medical review, assessment, and interpretation of clinical and safety data.
  • Support the preparation and review of clinical trial documents like Investigator’s Brochure, Informed Consent Document, and Clinical Study Reports.
  • Review MedDRA and WHO Drug Insight coding as necessary.
  • Lead the generation of SAE narratives and quality review of adverse event data.
  • Communicate SAEs to stakeholders within guidelines and timelines.
  • Draft Integrated Summary of Safety and Efficacy for clinical trial projects.
  • Review clinical trial protocols and protocol synopses in collaboration with cross-functional teams.
  • Develop Medical Monitoring Plans (MMP) and Risk Evaluation and Mitigation Strategies (REMS), where applicable.
  • Lead training for study team members and address protocol-related queries.
  • Ensure timely and accurate submission of regulatory documents.

Required Qualifications:

  • Education: MBBS MD Pharmacology
  • Experience: 2-5 years in clinical research or related fields.

Behavioral Skills:

  • Strong communication skills and team-oriented approach.
  • Ability to work effectively in a dynamic, fast-paced environment.
  • Strong organizational and prioritization skills to meet tight deadlines.
  • Creative problem-solving abilities.

Syngene Values:

  • Excellence
  • Integrity
  • Professionalism