Medical Monitor

Medical Monitor
  • Competitive
    HOUR
  • Permanent
  • Flagler Beach FL, US Flagler Beach FLAGLER US 32136
Job Ref: JO000122251
Sector: Administrative / Clerical
Sub-sector: Admin - Clerical
Date Added: 29 September 2021

Medical Monitor

At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.

Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry. We are seeking a highly motivated individual to join us as a Medical Monitor as part of the Project Delivery organization to work independently on handling of safety/medical issues according to company policies, SOPs and regulatory requirements. The Medical Advisor has the medical expertise, and specifically provides an authoritative opinion and answers medically based questions concerning medical, legal and regulatory matters.

Key Responsibilities:

  • Medical advice on study design and measurements in clinical trials
  • Review of the safety section in study protocols and investigators brochure
  • Review of safety listings as adverse events, laboratory listings, vital signs and ECG
  • Review of clinical trial reports from a safety perspective.
  • Medical assessment of AEs, SAEs
  • Medical review of individual safety cases, cumulative case listings, PSUR/PBRER, DSUR, Risk Management Plans
  • Literature review
  • Signal detection
  • Medical monitor in clinical trials
  • Contribute to department SOPs and tools
  • Accompany Commercial Operations colleagues on customer visits and participate in presentations when required

Requirements:

  • Ophthalmologist
  • Able to work in a fast-paced environment with changing priorities
  • Understanding of the Good Clinical Practice regulations, ICH guidelines, Pharmacovigilance legislation and internal SOPs
  • Excellent written and verbal communication skill
  • Experience in Medical Monitoring

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

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SRGTalent
30/10/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Shari Hulitt

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