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    Clinical Trial Manager Ii (Ctm Ii)

    Innovaderm Research
    5+ years
    Not Disclosed
    Canada
    12 Nov. 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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), Canada - North America

    Overview
    The Clinical Trial Manager II (CTM II) will oversee the operational management of clinical investigative sites and ensure the timely and high-quality delivery of clinical monitoring activities for clinical trials. The CTM II will be responsible for managing site performance, identifying issues, implementing corrective actions, and ensuring compliance with study protocols, standard operating procedures (SOPs), and regulatory requirements.

    Responsibilities

    Clinical Monitoring and Site Management

    • Oversee clinical monitoring activities to ensure timely and quality deliverables, in line with sponsor expectations and industry standards.
    • Identify and address quality issues related to site performance and monitoring activities through meetings, site reports, site visit follow-ups, and audits.
    • Serve as a primary contact for Clinical Research Associates (CRAs) and Lead CRAs, providing guidance and support.
    • Mentor and oversee CRAs and Lead CRAs to ensure their activities align with study requirements and timelines.
    • Review site visit reports, ensuring compliance and tracking metrics for quality.
    • Contribute to the development of the Clinical Monitoring Plan, ensuring alignment with project goals.
    • Prepare and conduct project-specific training sessions for CRAs.
    • Develop annotated site visit reports and monitoring tools, such as source data verification worksheets.
    • Conduct quality control visits and coordinate CRA meetings.
    • Perform co-monitoring visits alongside CRAs to ensure adherence to study protocols.
    • Participate in business development activities, including client meetings, proposal defense, and requests for proposals (RFPs).

    Leadership and Collaboration

    • Lead and guide the clinical trial team, ensuring that all members, including CRAs and Lead CRAs, are well-supported and aligned with project objectives.
    • Foster strong working relationships with clinical sites, colleagues, and sponsors to ensure smooth project execution.

    Ideal Profile

    Education

    • A B.Sc. in a relevant field (e.g., clinical research, nursing) or equivalent experience is required.

    Experience

    • At least 5 years of clinical research experience, including prior monitoring experience.
    • A minimum of 2 years acting in a Lead CRA or Clinical Team Leader role within the biotechnology, pharmaceutical, or CRO industry.

    Knowledge and Skills

    • Strong knowledge of ICH/GCP standards and regulatory requirements.
    • Proficiency in Microsoft Office suite (Word, Excel, PowerPoint).
    • Ability to manage multiple tasks in a fast-paced environment while establishing strong relationships with colleagues, sites, and sponsors.
    • Excellent leadership, organizational, time management, and problem-solving skills.
    • Occasional travel (up to 10% of the time), with potential for international travel once feasible.
    • Fluent in English (both oral and written); proficiency in French is an asset.
    • Experience in dermatology and working in a CRO environment is a plus.

    Why Innovaderm?

    Work Environment and Benefits

    • Flexible work schedule.
    • Permanent, full-time position.
    • Comprehensive benefits package: medical, dental, vision, RRSP, vacation, personal days, and more.
    • Option to work from home or Innovaderm’s headquarters in Montreal (subject to company policies and public health guidelines).
    • Ongoing learning and professional development opportunities.

    About Innovaderm

    Innovaderm is a specialized contract research organization (CRO) with a focus on dermatology. Since its founding in 2000, Innovaderm has established a strong reputation for delivering high-quality research and services to clients across North America and beyond. With a team of over 175 employees, Innovaderm continues to grow and expand, maintaining its commitment to providing the best in clinical research services.

    Commitment to Equity
    Innovaderm is dedicated to equitable treatment and equal opportunity for all applicants. We provide accommodations throughout the recruitment process for applicants with disabilities, upon request.

    Note: Only candidates eligible to work in Canada will be considered.

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