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Medical Monitor, Dermatology, Poland Or Spain

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

๐ŸŒ Now Hiring: Medical Monitor - Dermatology (Poland or Spain) ๐ŸŒ

๐Ÿ’ผ Position: Medical Monitor
๐Ÿข Industry: CRO - Medical Affairs
๐Ÿ“ Location: Poland or Spain
โณ Job Type: Full-time

๐Ÿ”Ž 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.

๐Ÿ”‘ Key Responsibilities

โœ” 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

โœ” 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

โœ” 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

โœ” 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

โœ” Additional Duties

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

๐Ÿ“Œ Requirements

๐ŸŽ“ Education:

  • Medical Degree
  • Completed residency training in Dermatology

๐Ÿ›  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

๐Ÿ“œ 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

๐ŸŽฏ Perks & Benefits

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

๐Ÿ“Œ Company: Innovaderm (Specialized in Dermatology CRO Research)
๐Ÿ“Œ Legal Requirement: Applicants must be legally eligible to work in Poland or Spain

๐Ÿ“ฉ Apply Now!