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Medical Monitor, Dermatology, Poland Or Spain

Innovaderm Research
Innovaderm Research
5+ years
Not Disclosed
10 Jan. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

🌍 Now Hiring: Medical Monitor - Dermatology (Poland or Spain) 🌍

💼 Position: Medical Monitor
🏢 Industry: CRO - Medical Affairs
📍 Location: Poland or Spain
Job Type: Full-time

🔎 Job Overview

As a Medical Monitor, you will provide crucial medical and scientific support throughout clinical research programs. Your responsibilities will include ensuring data integrity, subject safety, and clear communication with sites, investigators, and the internal project team. You will play an essential role in the smooth running of dermatology trials while adhering to the strict guidelines of clinical research.

🔑 Key Responsibilities

Protocols and Projects

  • Stay updated on study protocols, amendments, Investigator's Brochure, and other relevant research guidelines
  • Develop or review Medical Monitoring plans
  • Attend and present at Investigator’s and Safety Review Meetings
  • Provide 24/7 on-call support for urgent safety-related matters
  • Advise sites on protocol-related issues, including eligibility and safety

Medical Advisory Role

  • Be the primary contact for investigators, site personnel, and monitors regarding safety and protocol-related concerns
  • Evaluate medical eligibility, safety issues, and the appropriateness of subject dropout replacement

Data Activities

  • Provide medical consultation to the project team
  • Review subject safety-related data and assess trends, deviations, and adverse events (AEs)
  • Ensure proper coding of adverse events, medical history, and concomitant medications
  • Participate in central monitoring activities and risk management for safety issues

Safety Monitoring & SAE Reporting

  • Review Serious Adverse Events (SAEs) and write SAE narratives
  • Collaborate with pharmacovigilance teams to review safety queries and resolve outstanding issues
  • Assist with the creation of operating guidelines for safety committees

Additional Duties

  • Contribute to business development and proposal activities
  • Participate in the drafting of standard operating procedures for Medical Monitoring activities

📌 Requirements

🎓 Education:

  • Medical Degree
  • Completed residency training in Dermatology

🛠 Experience:

  • Minimum 5 years of clinical research experience in a CRO, pharmaceutical, or biopharmaceutical company
  • Minimum 3 years as a Medical Monitor or similar role in clinical trials

📜 Skills & Competencies:

  • Excellent knowledge of the drug development process
  • Ability to work independently and collaboratively within multidisciplinary teams
  • Strong organizational and prioritization skills
  • Excellent verbal, written, and interpersonal communication skills
  • Client-focused with a strong understanding of GCP, FDA, and Health Canada regulations

🎯 Perks & Benefits

Permanent full-time position
Flexible schedule
Remote work option (from Poland or Spain)
Ongoing learning and development opportunities

📌 Company: Innovaderm (Specialized in Dermatology CRO Research)
📌 Legal Requirement: Applicants must be legally eligible to work in Poland or Spain

📩 Apply Now!