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Clinical Trial Manager Ii (Ctm Ii)

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

🔍 Clinical Trial Manager II (CTM II)
📍 Location: Canada (North America)
🕒 Job Type: Full-time

✨ Why Innovaderm?

The Clinical Trial Manager II (CTM II) is responsible for overseeing the operational management of clinical investigative sites and clinical monitoring deliverables for clinical trials. You’ll ensure that all monitoring activities meet Sponsor satisfaction and regulatory requirements while identifying and addressing site performance issues. This role offers the opportunity to work with a Canadian-owned mid-sized CRO, building professional relationships and contributing to the success of clinical projects in dermatology and rheumatology.

🌟 Responsibilities

  • Clinical Monitoring Management:
    • Ensure clinical monitoring activities meet Sponsor requirements, including quality deliverables and adherence to SOPs and GCP standards.
    • Identify site performance issues and trends, develop action plans to address concerns.
    • Serve as a point of contact for CRAs and Lead CRAs, providing mentoring and oversight.
    • Conduct site visit report reviews, track compliance metrics, and ensure corrective actions are implemented.
  • Project Training & Development:
    • Contribute to the development of the Clinical Monitoring Plan.
    • Provide project-specific training for CRAs and create monitoring tools.
    • Conduct co-monitoring visits with CRAs and participate in business development activities.

🎓 Requirements

  • Education: B.Sc. in a relevant field (e.g., clinical research, nursing degree, or equivalent).
  • Experience:
    • Minimum of 5 years in clinical research, including at least 2 years in a Lead CRA or Clinical Team Leader role.
    • Experience in the biotechnology, pharmaceutical, or CRO industry.
    • Dermatology experience is a plus.
  • Skills:
    • Strong knowledge of ICH/GCP standards and regulatory requirements.
    • Proficiency in Microsoft Office (Word, Excel, PowerPoint).
    • Excellent leadership, time management, problem-solving, and organizational skills.
    • Fluent in English (French is an asset).
    • Occasional travel (up to 10%) required.

💼 Benefits & Work Environment

  • Flexible work schedule
  • Permanent full-time position
  • Complete benefits package: Medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities
  • Ongoing learning and development opportunities

🏢 About Innovaderm

Innovaderm is a CRO specialized in dermatology, providing high-quality research and services since 2000. Based in Montreal, Innovaderm continues to expand across North America and maintains a strong reputation in the industry.

📩 How to Apply

Submit your application today! Innovaderm is committed to providing equal opportunity and accommodations throughout the recruitment process.