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Clinical Trial Manager Ii, Dermatology & Rheumatology, Poland

8+ years
Not Disclosed
10 Jan. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc. 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: Clinical Trial Manager II, Dermatology & Rheumatology - Poland 🌟

πŸ’Ό Position: Clinical Trial Manager II (CTM II)
🏒 Industry: CRO - Clinical Operations
πŸ“ Location: Poland
⏳ Job Type: Full-time

πŸ”Ž Job Overview

The Clinical Trial Manager II (CTM II) will be responsible for managing clinical trial operations, including clinical monitoring activities, overseeing clinical investigative sites, and ensuring that deliverables are met in accordance with timelines and regulatory requirements. This role is ideal for someone with strong leadership skills, experience managing clinical monitoring activities, and an interest in dermatology and rheumatology.

πŸ”‘ Key Responsibilities

1. Clinical Monitoring Management

  • Ensure clinical monitoring activities are completed to the sponsor's satisfaction, in compliance with SOPs, GCP, and regulatory standards
  • Identify and address quality issues related to site performance and clinical monitoring activities

2. Team Leadership & Mentoring

  • Serve as the point of contact for CRAs and Lead CRAs, providing mentorship and oversight
  • Conduct site visit report reviews, track metrics, and ensure compliance with protocols
  • Conduct quality control visits with CRAs and oversee the development of annotated site visit reports

3. Training & Development

  • Prepare and deliver project-specific training for CRAs
  • Lead and coordinate CRA meetings and co-monitoring visits

4. Business Development & Client Interaction

  • Participate in business development activities, including proposal defenses, client meetings, and RFIs

πŸ“Œ Requirements

πŸŽ“ Education:

  • B.Sc. in clinical research, nursing, or a related field (or equivalent experience)

πŸ›  Experience:

  • Minimum of 8 years of clinical research experience, including at least 2 years in a Lead CRA or Clinical Team Leader role
  • Prior monitoring experience in the CRO, biotechnology, or pharmaceutical industry is required

πŸ’» Skills:

  • Strong knowledge of ICH/GCP standards and regulatory requirements
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)
  • Strong leadership, organizational, and problem-solving skills
  • Ability to work in a fast-paced, evolving environment
  • Fluent in English (oral and written); knowledge of dermatology is a plus

🎯 Perks & Benefits

✨ Flexible work schedule
✨ Home-based position with teleworking allowance
✨ Vacation, PPK, health allowance
✨ Ongoing learning and development opportunities

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

πŸ“© Apply Now!