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Project Manager (Poland)

5+ years
Not Disclosed
10 Jan. 30, 2025
Job Description
Job Type: Full Time Education: B.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

🔍 Project Manager
📍 Location: Poland
🕒 Job Type: Full-time

✨ Why Innovaderm?

As a Project Manager, you will play a pivotal role in ensuring the success of clinical trials managed by Innovaderm, overseeing key deliverables and guiding project teams to meet timelines and budget requirements. With a focus on significant multisite trials, including Global Phase III projects, this role offers an exciting opportunity to grow within a dynamic CRO.

🌟 Responsibilities

  • Client Interactions:
    • Serve as the primary contact for the sponsor and provide timely updates on trial progress.
    • Lead client calls and ensure all concerns are addressed efficiently.
  • Project Planning:
    • Participate in the preparation of essential project deliverables, including study plans, protocol, informed consent forms, and clinical study reports.
    • Ensure study sites have the necessary materials to conduct the study efficiently.
  • Quality and Risk Management:
    • Maintain “audit-ready” status for assigned studies.
    • Monitor quality across deliverables and manage risks to ensure project quality.
    • Review and respond to quality assurance audits.
  • Project Budget and Timelines:
    • Oversee project budgets, focusing on internal hours and identifying out-of-scope activities for change orders.
    • Manage trial timelines and resources, ensuring all tasks are completed on time.
    • Monitor recruitment status and implement strategies to meet recruitment timelines.
  • Project Team Leadership:
    • Lead and train the core project team, including Associate Project Managers and Project Coordinators.
    • Work with internal teams and vendors to ensure timely completion of tasks.

🎓 Requirements

  • Education: B.Sc. in a relevant discipline.
  • Certifications: PMP or PRINCE2 certification is an asset.
  • Experience:
    • 5+ years in industry, with at least 3 years leading multi-center clinical trials (Phase II-III).
    • Experience with concurrent, multi-country clinical trials.
    • Experience in study start-up, regulatory submission, clinical monitoring, or vendor management.
    • Dermatology trial experience is an asset.
  • Knowledge and Skills:
    • In-depth knowledge of GCP, ICH standards, and relevant FDA and local country regulations.
    • Proficiency in Microsoft Office suite.
    • Fluency in English (oral and written); additional languages are an asset.
    • Strong problem-solving abilities and teamwork skills.

💼 Benefits & Work Environment

  • Flexible work schedule
  • Home-based position
  • Permanent full-time position
  • Vacation and ongoing learning opportunities
  • Other benefits

🏢 About Innovaderm

Innovaderm is a CRO specializing in dermatology, with a reputation for high-quality research and exceeding client expectations. The company continues to grow across North America and Europe.

📩 How to Apply

Submit your application today! Innovaderm only accepts applicants who can legally work in Poland.